Food Recalls

[Kitchen Witch]

Ketek (telithromycin)
Audience: Infectious Disease, Hepatology and other healthcare professionals
[Posted 01/20/2006] Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

[January 20, 2006 ? Public Health Advisory ? FDA]
[January 20, 2006 ? Questions and Answers ? FDA]



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State Health Department Issues Warning on Juice Harvest Assorted Juices

Contact:
Ken August or Lea Brooks
(916) 440-7660

FOR IMMEDIATE RELEASE -- Sacramento, CA -- January 20, 2006 -- Consumers should not drink Evolution, Harvest or Trader Joe's brand assorted juices manufactured by Juice Harvest Corp. of San Bernardino because the products were not fully pasteurized and may contain harmful bacteria that pose a health risk, State Public Health Officer Dr. Mark Horton announced today. The containers list the following code dates: "1-12, 1-14, 1-17, 1-20 or 1-23." No illnesses associated with these products have been reported.

Approximately 8,000 units of the assorted juices in 16-, 32- and 64-ounce packages and one{omitted}gallon plastic containers distributed in Southern California are being voluntarily recalled. Customers who have purchased these products should return them to the place of purchase or dispose of them immediately. The California Department of Health Services is investigating to determine which distributors and retail establishments received these products.

The assorted juices being recalled are:

BRAND

NAME OF PRODUCT

CODE DATE

SIZE

Evolution, Harvest

Carrot Juice

1-12

16 oz, 32 oz

Evolution, Harvest

Organic Carrot Juice

1-12

16 oz, 32 oz

Evolution, Harvest

Carrot Celery Beet

1-12

16 oz

Evolution, Harvest

Carrot Parsley Spinach

1-12

16 oz

Evolution, Harvest

Incredible Vegetables

1-12

16 oz

Evolution, Harvest

Organic V

1-12

16 oz

Evolution

Essential Greens

1-14

16 oz

Evolution, Harvest,

Watermelon Juice

1-14

32 oz, 16 oz

Trader Joe's







Evolution, Harvest

Acai

1-14

16 oz

Evolution

SuperGreen

1-17

16 oz

Evolution

Orange Juice Past

1-20

32 oz, 64 oz

Evolution, Harvest

Old-Fashioned Lemonade

1-23

64 oz, 1 gal

Evolution, Harvest

Organic Lemonade

1-23

16 oz, 32 oz

Trader Joe's

Defense UP

1-17

16 oz

Evolution, Harvest

Bee Enerqized

1-17

16 oz

For more information about the products, consumers may contact Juice Harvest Corp. at (909) 478-0895.

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Pinnacle Foods Group Inc. Issues Allergy Alert on Undeclared Egg in Frozen "Aunt Jemima® Cinnamon French Toast" 12.5 oz. Cartons and Frozen "Aunt Jemima 'Home-Style' Low Fat Waffles" 20 oz. Cartons

Contact:
Mr. Kelley Maggs
973-541-6640

FOR IMMEDIATE RELEASE -- Mountain Lakes, NJ -- January 20, 2006 -- Pinnacle Foods Group Inc. of Mountain Lakes, NJ is recalling only the following products: Frozen AUNT JEMIMA CINNAMON FRENCH TOAST 12.5 oz. cartons and Frozen AUNT JEMIMA 'HOME STYLE' LOW FAT WAFFLES 20 oz. cartons with the lot codes listed below.

These products were manufactured with egg that is not listed on the carton. People who have an allergy or severe sensitivity to egg may run the risk of a serious or life-threatening allergic reaction if they consume this product.

This voluntary recall was initiated after the Company received an email from a consumer informing the Company that egg was not listed on the carton.

Retail Carton Code

Description - Retail Label Weight

Recommend Use By Date
(lot codes on or after are the issue)

19600-05130

AJ Low Fat Homestyle Waffle - 20 oz.

November 17, 2006

19600-05890

AJ French Toast Cinnamon - 12.5 oz.

June 12, 2006

If you are allergic to or have a severe sensitivity to eggs, you should not consume this product. Please return the product to the store where purchased for a full refund.

If you are not allergic to eggs, this product is safe to eat.

This announcement does not apply to any other Aunt Jemima frozen ready-to-eat items or other Aunt Jemima products such as pancake mixes or syrups.

Consumers with questions may contact the company at 1-800-554-5680.

The Food and Drug Administration has been made aware of this recall.


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Class 1 Recall: Vapotherm, Inc. Vapotherm® 2000i and 2000h Respiratory Gas Humidifier

Date Recall
Initiated:

October 13, 2005

Product:

Vapotherm® 2000i and 2000h Respiratory Gas Humidifier

Use:

The Vapotherm 2000i and 2000h Respiratory Gas Administration delivers moisture to and warms breathing gases through a flexible nasal tube for patients receiving supplemental oxygen. The environments of use include home, hospital or sub-acute institutional settings.

Recalling Firm:

Vapotherm, Inc.
108 Log Canoe Circle
Stevensville, MD 21666

Reason for Recall:

FDA has received reports of Vapotherm units becoming contaminated with Ralstonia spp, and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis (infection of the trachea), sepsis (infection in the bloodstream), pneumonia (lung infection), or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborms could develop pneumonia, sepsis and in the most severe cases, death.

Public Contact:

David Lain
Chief Regulatory Officer
Vapotherm, Inc.
198 Log Canoe Circle
Stevensville, MD 21012
410-604-3977

FDA District:

Baltimore

FDA Comments:

* FDA recommends the use of alternative devices until the source of the contamination has been identified.
* In October 2005, Vapotherm issued new procedures for disinfecting the Vapotherm® 2000i and 2000h humidifiers, but these procedures have not been effective in eliminating Ralstonia spp. contamination in the devices.
* Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection, which may include, but are not limited to:
* changes in temperature;
* poor feeding, irritability; and
* changes in hematologic indices.
* Clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.



Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.


For additional information, see the FDA?s 12/20/05 Preliminary Public Health Notification at http://www.fda.gov/cdrh/safety/122005-vapotherm.html.
Updated January 23, 2006

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Blooming Import Inc. Issues Allergy Alert on Undeclared Sulfites in Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates)

Contact:
Blooming Import Inc.
Moon Kee Lee
718-625-6868

FOR IMMEDIATE RELEASE -- Brooklyn, NY -- Jan. 24, 2006 --- Blooming Import Inc. 45 Bowne Street, Brooklyn, NY 11231 is recalling Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates) because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allege reactions if they consume this product.

The recalled Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates), packaged in uncoded 12 ounce heat sealed plastic bags were sold in New York City.

The recall was initialed after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of undeclared sulfites in Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates) in packages which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfites sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No Illnesses have been reported to date in connection with this problem.

Consumers who have purchased Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates) should return it to the place of purchase. Consumers with questions may contact the company at 1-800-680-3838.



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[Kitchen Witch]

Food and Drug Administration Seeks Injunction Against Pacific Shellfish, Inc.

The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pacific Shellfish, Inc., a seafood processor located at 5040 Cass Street in San Diego California, and Judd J. Brown, its President. An injunction is a court order to stop a firm from manufacturing, distributing, processing, or shipping a product. The government's complaint, filed on January 24, 2006 by the U.S. Department of Justice in the U.S. District Court for the Southern District of California, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by permitting ready-to-eat fish held and processed in Pacific Shellfish's facility to become contaminated.

According to the complaint, recent FDA inspections in 2004 and 2005 revealed the presence of Listeria monocytogenes (Listeria), a disease-causing bacterium, on Pacific Shellfish's processing equipment and fish products. Inspections since 2001 have also documented persistent insanitary conditions at the facility. FDA issued a letter to the firm on December 8, 2004, after an inspection revealed insanitary conditions and contamination with Listeria. Although the firm promised to correct its deficiencies, a 2005 inspection found that a persistent strain of Listeria remained and the firm had not implemented all of the promised corrections.

Listeria monocytogenesis the causal agent of listeriosis, a disease that can be very serious, even fatal, for high-risk groups such as pregnant women, unborn babies, newborns, and those with impaired immune systems. Although proper cooking can eliminate Listeria in fish products, raw fish products, such as those found in some types of sushi, pose a serious health risk if contaminated with Listeria. Even if fish is intended to be cooked, however, adequate sanitation is needed to prevent the spread of this strain of Listeria throughout the distribution system to restaurants and consumer homes, where it may contaminate ready-to-eat foods. The Listeria monocytogenes strain isolated from the 2004 and 2005 inspections was identical to a strain that has caused human illness.

The FDA has initiated this action to promote and protect the public health by enforcing the Federal Food, Drug, and Cosmetic Act. FDA's mission includes ensuring the safety or safety and effectiveness of a broad spectrum of regulated products, including food, human and animal drugs, vaccines, blood products, medical devices, electronic products that emit radiation, and cosmetics.


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Recall -- State Press Release
Undeclared Sulfites in Swad Brand Dry Dates

Contact:
Jessica A. Chittenden
518-457-3136

FOR IMMEDIATE RELEASE -- Maspeth, NY -- January 27, 2006 -- Acting Agriculture Commissioner Patrick H. Brennan today alerted consumers that Rajah Foods, 56-05 55th Drive, Maspeth, New York is recalling "Swad brand Dry Dates" due to the presence of undeclared sulfites. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product.

The recalled "Swad brand Dry Dates" are packaged in a 7-ounce, uncoded plastic bag. It was sold throughout New York, New Jersey, Connecticut, Massachusetts, Delaware, Maryland, and Virginia. It is a product of India.

Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date to this Department in connection with this problem.

Consumers who have purchased "Swad brand Dry Dates" should return them to the place of purchase.

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Hasty Tasty Food Service Recalls Sandwiches Due to Undeclared Allergens

Contact:
Hasty Tasty Food Service Inc.
(563) 333-6783

FOR IMMEDIATE RELEASE -- Davenport, IA -- January 27, 2006 -- Hasty Tasty Food Service Inc./DBA Valley Vending of Davenport Iowa is recalling the following items: Chicken Salad, Egg Salad, Ham Salad, and Tuna Salad sandwiches because they contain undeclared Dairy allergens (sweet dairy whey and butter). People who may have an allergy or severe sensitivity to Dairy products run the risk of serious or life threatening allergic reaction if they consume these products.

The Chicken Salad, Ham Salad, Egg Salad sandwiches were labeled under the brand names of Valley Vending/Hasty Tasty, Venture Vending, Prime Vending, and M & M Vending. Only the Tuna Salad Sandwiches were labeled with the Valley Vending/Hasty Tasty label. The sandwiches were distributed in the states of Iowa and Illinois through our mobile catering trucks and/or vending machines.

These products can be identified by the brand name and are packaged in a plastic wedge container with a date code on or before 1/26/06. The net weight on the label is 4.5 oz.

No illnesses have been reported to date.

The recall was initiated after it was discovered that our sliced bread containing sweet dairy whey and butter was distributed in packaging that did not reveal the presence of these listed allergens on the label. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes. All products have been pulled from distribution and label corrections have been completed.

Anyone with questions concerning this matter may contact Hasty Tasty Food Service Inc./DBA Valley Vending at (563) 333-6783.


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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
The First Years® Announces Voluntary Recall of Liquid-Filled Teethers

Contact:
The First Years Recall Hotline
1-866-725-4407

FOR IMMEDIATE RELEASE -- STOUGHTON, MA -- January 27, 2006 -- The First Years, a subsidiary of RC2 Corporation, is voluntarily recalling liquid filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid from the teether is ingested.

Consumers should stop using the recalled products immediately.

Products:

* Disney Days of Hunny Soft Cool Ring Teether--Style# Y1447
* Disney Soft Cool Ring Teether--Style# Y1470
* Disney Soft Cool Ring Teether--Style# Y1490
* The First Years® Cool Animal Teether/Fish, Zebra and Dinosaur designs--Style# Y1473
* The First Years® Floating Friends Teether-- Style# Y1474
* Sesame Beginnings? Chill & Chew Teether-- Style# Y3095

This recall is for 6 different styles of liquid-filled teethers for infants (3+ months old) to soothe gums during the feeding stage. The 6 styles affected have the same general construction of a durable vinyl exterior with clear liquid pre-filled inside. Some designs have printed graphics while others have floating internal characters.

No illnesses have been reported to date in connection with this problem.

The teethers are sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006 for $2.99 to $3.99.

Consumers should put the teether in its current condition into a sealed plastic storage bag, place in envelope, and return to: Parent Service Center, RC2/The First Years, 100 Technology Center Drive, Stoughton, Massachusetts, 02072. Consumers should include their mailing address in the envelope to receive a replacement teether and free gift.

Consumer Contact: For additional information, consumers can visit: www.thefirstyears.com or call The
First Years Parent Service Center at 1-866-725-4407.

This recall is being made with the knowledge of the US Food and Drug Administration. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. Or, on the MedWatch web site at www.fda.gov/medwatch.

[Kitchen Witch]

Recall Notification Report 002-2006
[ ]
Product(s) Recalled:
Asian Style Pot Stickers

Production Dates/Identifying Codes:
Produced 09/19/2005

The following product is subject to recall:

* 9-ounce packages of Stouffer's "LEAN CUISINE® ASIAN-STYLE POT STICKERS," chicken & vegetable dumplings with rice in an Asian-Style dipping sauce. Each package contains the package code, "5262595512," the words "Best before Oct. 2006" and the establishment number, "P-7991," printed on the right side flap.


Problem/Reason for Recall:
The product may contain extraneous materials (small hard plastic fragments).

How/When Discovered:
The Company notified FSIS after receiving consumer complaints. There were no reports of injury.

Federal Establishment:
07791 P
Nestlé Prepared Foods Company
2130 Old Georgia Highway
Gaffney, SC 29340

Consumer Contact:
Nestlé Consumer Services, 800-993-8625

Media Contact:
Roz O'Hearn, Manager, Marketing Communications, (440) 264-5170

Quantity Recalled:
Approximately 54,690 pounds

Quantity Recovered:
To Be Determined

Distribution:
Nationwide

Recall Classification:
Class II

Recall Notification Level:
Retail

Press Release:
South Carolina Firm Recalls Asian-Style Pot Stickers That May Contain Pieces of Plastic

Direct Notification Means:
The firm has notified its customers verbally and will follow-up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (919) 844-8400
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
January 23, 2006

Recall Case Number:
002-2006







Recall Notification Report 003-2006
[ ]
Product(s) Recalled:
Sirloin Beef and Asian Style Vegetables

Production Dates/Identifying Codes:
Produced November 11, 2005

The following product is subject to recall:

* 9.0 Oz boxes of "WEIGHT WATCHERS® SMART ONES® SIRLOIN BEEF AND ASIAN STYLE VEGETABLES," in a zesty teriyaki sauce. Each box includes the establishment number, "EST. 1869" inside the USDA mark of inspection and a best if used by date of "11/07." Each box bears the code "MS 5 L 11 BD 2."


Problem/Reason for Recall:
The package indicates that the product is sirloin beef and Asian style vegetables; however, inside the package is roast beef in Portobello vermouth sauce with broccoli and cauliflower. The package labels do not specifically state that milk protein, a potential known allergen, is an ingredient.

How/When Discovered:
The Company received a consumer complaint and reported the incident to FSIS.

Federal Establishment:
01869 M
Heinz Frozen Foods
1301 Oberlin Road S.W.
Massillon, OH 44647

Consumer Contact:
Consumer Affairs Department, 1-800-551-0140

Media Contact:
Robin Teets, Senior Manager, Public Relations, (412) 237-3562

Quantity Recalled:
Approximately 1,561 pounds

Quantity Recovered:
To Be Determined

Distribution:
Florida, Maryland, Missouri, Pennsylvania, Virginia and Washington, DC

Recall Classification:
Class I

Recall Notification Level:
Consumer

Press Release:
Ohio Firm Recalls Sirloin Beef and Asian Style Vegetables Due To Undeclared Allergen

Direct Notification Means:
The firm has notified its customers orally and will follow up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (630) 620-7474
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
January 23, 2006

Recall Case Number:
003-2006





Recall Notification Report 004-2006
[ ]
Product(s) Recalled:
Sausages

Production Dates/Identifying Codes:
The following products are subject to recall:

* 2 ½- and 5-pound jars of "MEXICAN BRAND, MADE IN MICHIGAN, RED HOTS SAUSAGE, SMOKED FLAVOR ADDED, PACKED IN SOLUTION OF VINEGAR AND SALT." Each label includes the establishment number, "EST. 10116" inside the USDA mark of inspection.
* 5-pound jars of "RED HOTS, Smoked Sausage, PACKED IN SOLUTION OF VINEGAR WATER AND SALT." Each label includes the establishment number, "EST. 10116" inside the USDA mark of inspection.


Problem/Reason for Recall:
The product labels do not specifically state that milk, a known allergen, is an ingredient.

How/When Discovered:
The problem was discovered by FSIS.

Federal Establishment:
10116 M
Kubisch Sausage Co.
50400 Rizzo Dr.
Shelby Twp, MI 48315

Consumer Contact:
Vaso Marcovich, President, (586) 566-4661

Media Contact:
Vaso Marcovich, President, (586) 566-4661

Quantity Recalled:
Unknown

Quantity Recovered:
To Be Determined

Distribution:
Michigan

Recall Classification:
Class I

Recall Notification Level:
Retail

Press Release:
Michigan Firm Recalls Sausage Products Due To Undeclared Allergen

Direct Notification Means:
The firm has notified its customers verbally and will follow-up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (60 240-4080
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
January 27, 2006

Recall Case Number:
004-2006

[Kitchen Witch]

Class 1 Recall: Boston Scientific Flextome® Cutting Balloon Systems
Date Recall
Initiated:

December 7, 2005
Product:
Flextome Cutting Balloon® Device Monorail® Delivery System
Use:
The Flextome Cutting Balloon® system is used to open blocked arteries or blood vessels. It consists of a surgical balloon with microsurgical blades attached to the sides. The balloon is inserted into the artery with a catheter, and then dilated. When the balloon expands, the microblades cut through fatty deposits, widening the blocked artery.
Recalling Firm:
Boston Scientific Corporation
3574 Ruffin Road
San Diego, California 92123-2597
Reason for Recall:
The catheter shaft used to place the balloon in the artery may separate during withdrawal of the device from the patient. If that happens, the procedure may be prolonged, or more in-depth surgery may be required to remove the broken-off piece from the artery.
Public Contact:
Abe Matthews
Vice President of Regulatory Affairs
Boston Scientific Corporation
3574 Ruffin Road
San Diego, California 92123-2597
858-254-7885
FDA District:
Los Angeles
FDA Comments:

* This product should no longer be used on patients and should be returned to Boston Scientific.
* This action does not affect patients who have already received treatment, because the problem occurs during the procedure.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.


A copy of the company's press release regarding this recall can be found on the company's website.








Class 1 Recall: Baxter Healthcare Corp. COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps

Date Recall
Initiated:

December 13, 2005

See also:

* September 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps
* July 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps

Product:

All models of Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps.
Affected Models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Use:

These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.

Recalling Firm:

Baxter Healthcare Corporation
Rt. 120 & Wilson Road
Round Lake, IL 60073

Reason for Recall:

Battery Undercharging: The pump?s battery charge level indicator may overstate the battery power level and shut down when operating on battery power if not charged for a full 12 hours following a ?low battery? alarm.
False Air Detection Alarms: If the pump?s tubing is stretched or pulled, the pump?s sensors may misinterpret this tension as air in the line, resulting in a false alarm and shutting down the pump.
Gearbox Wear: Worn parts in the pump?s motor can cause the pump to shut down and interrupt therapy.
Under-infusion: If there is an obstruction during tube-loading, the upper jaw of the pump head can be moved out of alignment, resulting in insufficient fluid delivery.
Non-detection of upstream occlusion: Improperly spiked bags, use of a source container which has had all air removed, improper venting of the container, and an unopened air vent above the burette chamber may result in the pump not detecting an upstream occlusion.

Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered.

Public Contact:

Center for One Baxter
Baxter Healthcare Corporation
1 Deerfield Parkway
Deerfield, IL 60015
800-422-9837

FDA District:

Chicago

FDA Comments:

* FDA has issued previous recall notices for the COLLEAGUE® Volumetric Infusion Pumps. Information explaining the reason for these recalls can be found on the Agency?s web site:
* September 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps
* July 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps

* Baxter sent a December 13, 2005 Urgent Device Correction Notice to all COLLEAGUE® customers alerting them to the additional problems with the pump identified in this notice. The letter included instructions for reducing the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be distributed to all users of the Colleague pump.

* Baxter also informed customers that they would be notified when the new release of the COLLEAGUE® Volumetric Infusion Pump Operator?s Manual is available.

* COLLEAGUE® customers with questions may contact Baxter?s Medication Delivery Services at 1-800-843-7867.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.



Consumers with questions may contact the company at 800-422-9837, or visit Baxter?s website.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Ingles Markets, Incorporated Issues Local Recall for Old Fashion Apple Pie

Contact:
Tim Davey
(82 669-2941 (Ext. 391)

FOR IMMEDIATE RELEASE -- Asheville, NC. -- February 3, 2006 -- Ingles Markets, Incorporated of Asheville, N.C., is recalling its 9" Old Fashion Apple Pie because they may contain undeclared walnuts in the pie topping. People who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.

The recall was initiated after it was discovered that some of the pies were mislabeled and did not disclose the presence of walnuts in the topping. The product comes in a clear plastic package marked with the sell by date of January 31, 2006, or before. The recalled 9" Old Fashion Apple Pies were sold in Ingles retail stores located in AL, GA, NC, SC, TN and VA. Customers who have purchased the product may return it to the store for a full refund or replacement. All 9" Old Fashion Apple Pies currently for sale are labeled correctly. Customers with questions may contact Ingles at 1-800-635-5066 extension 426.

[Kitchen Witch]

FDA News

FOR IMMEDIATE RELEASE
P06-19
February 8, 2006

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Issues Public Health Advisory for Trasylol

The Food and Drug Administration today issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."

FDA advises health care providers to be aware of the following:

* Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
* Physicians should consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
* FDA is working with the manufacturer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine.
* Patients should discuss all major risks for heart bypass surgery with their healthcare providers. These include the risks for bleeding and the available ways to lessen the risk for bleeding.

Trasylol (aprotinin injection) is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. The drug aids the body's ability to stop bleeding and is used to lessen the bleeding risk during this surgical procedure. This surgery is done to bypass clogged arteries.
.
FDA is evaluating the studies more closely, along with other scientific literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted. One study, published in the New England Journal of Medicine, reported that patients who received Trasylol had higher rates of serious kidney problems, heart attacks, and stroke compared to treatment with other drugs to prevent bleeding or to no treatment; the second study, reported in Transfusion, reported more cases of decreased kidney function in patients treated with Trasylol compared to another treatment to prevent bleeding. A limitation of both studies was that doctors chose which patients were to receive Trasylol or another treatment. It is possible that patients treated with Trasylol may have been sicker than other patients. The studies used complex statistical methods to adjust for possible differences in patient risk factors.

The agency also anticipates convening an advisory committee meeting in 2006 to discuss the existing data about the risks and benefits of Trasylol, and if additional safety measures need to be taken. The FDA will notify health care providers and patients in a timely manner following further scientific investigation of adverse event reports.

FDA also urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1800-FDA-108, by fax (1-800-FDA-107 or internet.

The Public Health Advisory is available on line at http://www.fda.gov/cder/drug/advisory/aprotinin.htm.

For more information please visit http://www.fda.gov/cder/drug/infopag...in/default.htm,

####

[Kitchen Witch]

FDA News

FOR IMMEDIATE RELEASE
P06-21
February 9, 2006

Media Inquiries:
Stephen King, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers to Stop Using Recalled Liquid-Filled Children?s Teething Rings Manufactured by RC2 Brands (The First Years)

The U.S. Food and Drug Administration (FDA) is advising consumers to stop using liquid-filled children's teething rings manufactured by RC2 Brands (The First Years) because the liquid contained in these rings is contaminated with bacteria that may cause serious illness if swallowed by babies, enters the lungs, or is absorbed through a cut in the mouth.

The risk of illness is especially high in infants whose immune systems are compromised by underlying issues such as malnutrition, blood problems, or as a result of cancer therapy.

RC2 Brands (The First Years), which is located in Stoughton, Massachusetts, stopped distributing the teethers and began a recall of these products in January 2006.

"FDA is closely monitoring the recall to ensure that all these teething rings are removed from the market and that consumers are alerted to the problem," said Dr. Daniel Schultz, Director of FDA's Center for Devices and Radiological Health. "The agency is also taking a careful look at other RC2/The First Year products to determine if any others are contaminated with the bacteria."

The teething rings were sold nationwide between July 2005 and January 2006 at major retailers, and grocery, drug, and specialty stores. Approximately 352,000 have been distributed in the United States. The specific products subject to the recall are:

* Disney Days of Hunny Soft Cool Ring Teether -- Style #Y1447
* Disney Soft Cool Ring Teether -- Style #Y1470
* Disney Soft Cool Ring Teether -- Style #Y1490
* Sesame Beginnings Chill & Chew Teether -- Style #Y3095
* The First Year's Cool Animal Teether, fish, zebra, and dinosaur designs -- Style #Y1473
* The First Year's Floating Friend Teether -- Style # Y1474

FDA has determined that the firm's action constitutes a Class I recall, a situation in which there is a reasonable chance that use of the product will cause serious health problems or death. To date, the firm has received 105 complaints of fluid leakage, 14 reports of sharp edges that resulted in 9 incidents of cuts, and 2 reports of babies biting through the rings. The teething rings are manufactured in Hong Kong and have been sold in both the United States and Canada.

The firm is asking consumers who purchased one of the recalled teethers to place it in a plastic bag and return it to:

Parent Service Center
RC2/The First Years
100 Technology Center Dr.
Stoughton, Mass., 02072

For additional information, consumers can contact the firm's service center at 1-866-725-4407, or go to the firm's web site: www.thefirstyears.com.

Any adverse reactions or quality problems experienced with use of these teethers should be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch.

[Kitchen Witch]

Benzocaine sprays
Audience: Healthcare professionals and patients
[Posted 02/13/2006] FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. The FDA is highlighting safety information previously addressed by the Agency (see below), has provided other information for the consideration of clinicians in the PHA and will make further announcements or take action as warranted by the ongoing review.

[February 10, 2006 ? Public Health Advisory ? FDA]
[January 2003 - FDA Patient Safety News - FDA]

[Kitchen Witch]

FDA-Requested Recall - Cytosol Laboratories, Inc.
Product Contains Dangerous Levels of Endotoxin

The U.S. Food and Drug Administration (FDA) today delivered a letter to Cytosol Laboratories, Inc., of Braintree, Mass., to request a recall of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures. BSS is a drug used by health professionals to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery.

FDA requested the recall because product lots were found to have elevated levels of endotoxin. Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome(TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories, Inc.

The FDA requests that the company take immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals. An FDA-requested recall is initiated to protect the public health when a product that has been distributed represents a risk of illness or injury and the firm has not initiated a recall of the product. FDA is instructing hospitals, physicians, and consumers to immediately stop using any of these products, quarantine any remaining product, and if no return instructions from Cytosol are received, destroy the product.

An estimated one million units of BSS products were distributed between December 2003 and December 2005. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

Individuals with questions may call FDA at 1-888-463-6332. Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm , by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

AMO Recall release: http://www.eyeworld.org/ewweek.php?i...amo%20recall#2

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Flying Salmon, Inc. Issues Alert on Undeclared Soybean in Variety of Tobiko Caviar Repacks

Contact:
Flying Salmon Inc.
1-800-622-8427

FOR IMMEDIATE RELEASE -- San Francisco, CA -- February 14, 2006 -- Flying Salmon Inc. of San Francisco, California is recalling:

* "Carpathian" Brand repacked Japanese Orange Tobiko Caviar in 2oz, 4oz, & 8oz containers
* "Carpathian" Brand repacked Japanese Wasabi Tobiko Caviar in 2oz, 4oz, & 8oz containers
* "Carpathian" Brand repacked Japanese Black Tobiko Caviar in 2oz, 4oz, & 8oz containers

because they may contain undeclared SOYBEAN. People who have an allergy or severe sensitivity to
Soybean run the risk of serious or life-threatening allergic reaction if they consume these products.

The above listed products were distributed in the Northern California area where the products may have been distributed and reached the consumers through retail stores.

The products are packed under the brand name "Carpathian". It may be in 2oz and 4oz plastic or glass jars. The 8oz container is plastic only. The containers in question will not have any ingredient labels attached to its sides.

"No illnesses have been reported to date".

The recall was initiated after FDA inspectors, during a routine inspection, discovered that the variety of the Tobiko Caviar (mentioned above) containing SOYBEAN were distributed in packaging that did not reveal the presence of SOYBEAN. Subsequent investigation indicates the problem was caused by a temporary breakdown in company?s production and packaging processes.

Consumers who have purchased the "The Variety of Tobiko Products" of the "Carpathian" Brand are urged to return the product to the place of purchase for a full refund. Consumers with questions may contact FLYING SALMON, INC. at 1-800-622-8427.

[Kitchen Witch]

Recall -- State Press Release
Consumer Alert: Undeclared Milk in Keikitos (Muffins)

Contact:
Jessica Chittenden
518-457-3136

FOR IMMEDIATE RELEASE -- February 15, 2006 -- State Agriculture Commissioner Patrick H. Brennan today alerted consumers that Marito's Bakery, 521 Union Ave., Westbury, New York 11590 is recalling 8 ounce packages of "Keikitos" (muffins) due to an undeclared milk ingredient. People who have allergies to milk may run the risk of serious or life-threatening allergic reactions if they consume this product.

The recall includes all codes of "Keikitos" (muffins) in 8 ounce plastic bags. It was sold in Long Island, New York, and New Jersey.

The problem was discovered as a result of routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department's Food Laboratory personnel revealed the presence of a milk ingredient in product packages which did not declare a milk ingredient on the label.

No illnesses have been reported to date to this Department in connection with the problem.

Consumers who have purchased "Keikitos" (muffins) should return it to the place of purchase.

[Kitchen Witch]

FDA News

FOR IMMEDIATE RELEASE
P06-24
February 16, 2006

Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Stronger Warnings for Tequin

Today, Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes, announced by the Tequin manufacturer in a letter to healthcare professionals, update the prescription information as a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin. Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.

Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002. Today's changes strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.

The FDA will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to patients.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
La Preferida, Inc. Announces Limited Voluntary Recall of 15 oz. Cans of Whole Pinto Beans

Contact:
Patrick O?Connor
312-573-5510

FOR IMMEDIATE RELEASE -- Chicago, IL -- February 17, 2006 -- La Preferida, Inc. announced today the voluntary recall of a limited number of its brand-name 15-ounce cans of whole pinto beans as a precautionary measure after a consumer in De Kalb, Ill. reported finding a bird's head in a 15 oz. can of the product.

La Preferida is working closely with federal, state and local health agencies to investigate the incident. Testing is expected to take place next week to determine how and when the object got into the can.

No injury or illness has occurred as a result of the incident. The company has not received any similar reports.

The batch affected by the recall bears the lot number 5348 MF on the lid. The batch was canned on December 14, 2005 and is marked with a "best by" date of 12/14/07. The product was canned on behalf of La Preferida by New Meridian Inc. of Eaton, Indiana. No other batch of La Preferida pinto bean cans is affected by the recall, nor are any other La Preferida products.

"The safety of our customers is paramount to La Preferida," said David Brand, Director of Quality Assurance for La Preferida, Inc. "La Preferida prides itself on a more than 50 year history of quality and safety. We are actively working with New Meridian to review their operations and food safety procedures."

La Preferida initially contacted the De Kalb County Health Department and subsequently coordinated the response to the incident with the Illinois Department of Public Health and the U.S. Food and Drug Administration.

"Everyone shares the same goal of ensuring the safety of consumers," said Brand. "We are committed to assisting in the review of this matter in any way we can."

As an initial precaution after receiving the call from the consumer, La Preferida immediately removed all 15 oz. pinto bean cans from the store where the can was purchased. On Friday afternoon, the consumer turned the can over to the De Kalb County Health Department.

"There are still many unanswered questions, but we have decided to err on the side of safety," said Brand. "We await the results of a more detailed analysis to help us ascertain how the object found its way into the can."

La Preferida is working with its distributors to notify points of sale and remove this limited batch of the product from the market.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Best Brands Corp. Issues Allergy Alert on Undeclared Soy in Danish Twist Product

Contact:
Bob Bianca
1-800-866-3300 ext. 7569

FOR IMMEDIATE RELEASE -- February 17, 2006 -- Best Brands Corp. of Eagan, Minnesota is recalling all lots of Twisted Snails Frozen Danish Dough, because they contain undeclared soy . People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. The products are not harmful unless the consumer is allergic to soy.

The Danish twist dough was sold to retail and grocery store bakeries and other foodservice outlets. Consumers may have purchased the product as baked, spiral-shaped Danish, either iced, filled, or plain. The Danish twists may have been sold from trays in the bakery counter or in individual packages with grocery store labels. The name "Best Brands" or "Twisted Snails Frozen Danish Dough" would not appear on the consumer package.

The Danish twist dough was distributed to retail bakeries, grocery store bakeries and other foodservice outlets in Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Pennsylvania, Ohio, South Dakota, Texas, and Wisconsin.

The recall was initiated after it was discovered that product containing soy was distributed in packaging that did not reveal the presence of soy. In the future, the product will be distributed with the correct ingredient listing.

Consumers with allergen concerns who have purchased Danish twists are urged to contact the place of purchase to determine if their Danish twists were made from the Best Brands Corp. Twisted Snails Danish dough and are part of this recall. The Danish twists may be disposed of or returned to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-328-2068.

Best Brands Corp. is taking this voluntary action to ensure the safety of its consumers and is working closely with the U.S. Food & Drug Administration in the recall process. Best Brands Corp. is committed to the quality and safety of its products and sincerely regrets any inconvenience that this incident may have caused.

[Kitchen Witch]

Nationwide Infant Formula Recall

FDA Informs Public of Nationwide Infant Formula Recall

The U.S. Food and Drug Administration (FDA) is alerting the public to a recall being conducted by Mead Johnson for their GENTLEASE powdered infant formula, lot number: BMJ19, use by 1 Jul 07. This lot was found to contain metal particles, consisting of up to 2.7 millimeter in size.

No illnesses have been reported to date. However, in the rare instance that an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant?s respiratory system and throat. Any injuries associated with this problem would be likely to show up within three to four hours. The symptoms could be varied depending on whether there is damage to the throat or lungs. Damage to the throat may include coughing, difficulty swallowing or difficulty breathing. Similarly damage to the lungs could include coughing and difficulty breathing. If you may have fed this lot of GENTLEASE to your baby, and you have any concerns about your baby?s health, you should contact your baby?s health professional for guidance.

There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase. The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07.

Mead Johnson informed the FDA of this problem. FDA and Mead Johnson are currently investigating the cause of the metal particles found in the infant formula in this highly unusual incident.

Consumers who have a can of this batch of GENTLEASE powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Walnuts in Brownberry Natural Wheat Bread

Contact:
Arnold Foods Company, Inc.
1-800-984-0989

FOR IMMEDIATE RELEASE -- HORSHAM, PA -- February 23, 2006 ? Arnold Foods Company, Inc. is recalling Brownberry brand Natural Wheat Bread (24 ounces) sold in Alabama, Florida, Georgia, North Carolina, South Carolina and Tennessee because it may contain undeclared walnuts. People who have an allergy to walnuts run the risk of life threatening or serious allergic reactions if they consume the product.

The product being recalled has a blue or white square lock tab closure with a code date of "Feb 27" printed on the lock tab closure.

The company announced the recall after receiving reports from two consumers who found walnuts in the bread which are known allergens that were not named on the ingredient list. The company has received no other reports from consumers. There are no reports of injuries.

All products with the above code date are being removed from store shelves. No other Arnold brand or Brownberry brand products are affected.

Consumers with allergies to walnuts who have purchased the product can return the product to its place of purchase for a full refund or call the company at 1-800-984-0989.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Federico?s Bakery Issues Allergy Alert on Undeclared Sodium Bisulfite

Contact:
John Lee
(626)357-3243 X13

FOR IMMEDIATE RELEASE -- Duarte, CA -- February 23, 2006 -- FEDERICO'S BAKERY of Duarte, California is recalling its "Apricot-filled Butter Cookies" because they contain Sodium-Bisulfite in the Apricot filling. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled "Apricot-filled Butter Cookies" were distributed in California in retail stores. The product comes in a clear plastic package and is contained in the following item numbers:

Item No.

Description

Size

VS 118

Italian Deluxe Assortment

13.50 oz

VS 119

Fancy Butter Cookie Assortment

11.50 oz

VS 122

Butter Cookie Apricot Center

11.50 oz

VS 123

Assorted Butter Cookies

11.50 oz

V118

Deluxe Italian Assortment

32 oz

V119

Fancy Butter Cookies

32 oz

No illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered that the Sodium-Bisulfite containing product was distributed in packaging that did not reveal the presence of Sodium- Bisulfite. Subsequent investigation indicates the problem was caused by not properly labeling the Sodium-Bisulfite in the packages.

Consumers who have purchased the packages above are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-626-357-3243 extension 13.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Galerie Issues Allergy Alert on Undeclared Peanuts in Choxie Truffles

Contact:
Allen Buchman
1-859-538-8500

FOR IMMEDIATE RELEASE -- Hebron, KY -- February 23, 2006 -- Ross Acquisition Co. Inc., dba Galerie? of Hebron, KY is recalling all lots of 4.95 oz packages of CHOXIE? brand truffles and balls as they may contain undeclared peanuts or peanut butter. People who have allergies to peanuts run the risk of serious or life-threatening reaction if they consume these products. Product in this recall is:

CHOXIE? Double Dark Truffles UPC Code 768395345129

The following are also being recalled as a precautionary measure, not because of an undeclared allergen.

CHOXIE? Milk Chocolate Truffles UPC Code 768395345099
CHOXIE? Milk Chocolate Peanut Butter Balls UPC Code 768395345105
CHOXIE? Milk Chocolate Caramel Balls UPC Code 768395345112

The recalled items were distributed to and sold in Target? and SuperTarget? retail stores nationwide.

The products come in 4.95 oz clear acetate packages marked with UPC code listed above on the back bottom left corner. No illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered that CHOXIE? Milk Chocolate Peanut Butter Balls were within packages of CHOXIE? Double Dark Truffles.

Production of the products has been suspended until the company and FDA are certain that the problem has been corrected.

Consumers who have purchased these items are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-859-538-8500.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Hanford Pharmaceuticals Issues a Nationwide Recall of Cefazolin for Injection Because of Possible Health Risk

Contact:
G.C. Hanford Manufacturing Co.
315-476-7418

FOR IMMEDIATE RELEASE -- Syracuse, NY -- February 24, 2006 --- Hanford Pharmaceuticals Inc., of Syracuse, NY, is voluntarily recalling four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials , an antibiotic used in a hospital environment. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus ) which may pose a serious or life-threatening risk for some patients. Cefazolin for Injection, USP is used to treat skin and skin structure, respiratory and other infections.

The firm is notifying its customers and users of the recall by letter, and asking that they stop distribution, recall from their accounts, and request the return of the recalled lots. Hospitals, clinics, and users should stop using the affected lots immediately. The letter advises that the product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Check the lot numbers on the product label and promptly return any with the following lot numbers: Sandoz product - C4650, C4537; Watson product - C4689, C4665.

Patients who feel that they may have experienced an adverse reaction to recalled product should seek medical help. Patients or users can contact the firm at (315) 476-7418.

To date, the firm has not received any confirmed reports of adverse events or complaints related to the recalled lots.

Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

[Kitchen Witch]

Recall Notification Report 005-2006
[ ]
Product(s) Recalled:
Chicken Egg Rolls

Production Dates/Identifying Codes:
Produced December 8, 2005. The following products are subject to recall:

* 36-ounce packages of "China Express, Chicken Egg Rolls, With Sweet & Sour Sauce Packets, 12 Count." Each package bears the establishment number "P-13218" inside the USDA mark of inspection. The packages also bear the case code "2003425" or "1003425."


Problem/Reason for Recall:
The packages state that the egg rolls are filled with chicken, but they may instead contain shrimp, a known allergen.

How/When Discovered:
The establishment received two consumer complaints, reported the incidents to FSIS and the recall information was received on February 16, 2006.

Federal Establishment:
13218
Chung's Gourmet Foods
3907 Dennis Street
Houston, TX 77004

Consumer Contact:
Areg Sahakian, Director of Human Resources, (713) 741-2118 or (800) 824-8647

Media Contact:
Areg Sahakian, Director of Human Resources, (713) 741-2118 or (800) 824-8647

Quantity Recalled:
Approximately 6,426 pounds

Quantity Recovered:
To Be Determined

Distribution:
Nationwide

Recall Classification:
Class I

Recall Notification Level:
Retail

Press Release:
Texas Firm Recalls Chicken Egg Rolls Due To Undeclared Allergen

Direct Notification Means:
The firm has notified its customers verbally and will follow-up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (214) 767-9116
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
February 16, 2006

Recall Case Number:
005-2006

[Kitchen Witch]

Recall Notification Report 006-2006
[ ]
Product(s) Recalled:
Beef Sausage

Production Dates/Identifying Codes:
Produced November 7, 2005. The following products are subject to recall:

* 12-ounce packages of "Hi-Country, JALAPEÑO BEEF LOG, REFRIGERATE AFTER OPENING." The package bears the establishment number "Est. 1248" inside the USDA mark of inspection and the use by/sell by date "11-7-06."


Problem/Reason for Recall:
The product may be contaminated with microbiological pathogens.

How/When Discovered:
FSIS discovered the problem during inspection activities and the establishment initiated a recall.

Federal Establishment:
01248 M
Hi-Country Snack Foods, Inc.
1 Lincoln Gulch RD
Lincoln, MT 59639

Consumer Contact:
Chris Castagne, Production Manager, (406) 362-4203

Media Contact:
Dean Yonkovich, General Manager, (406) 362-4203

Quantity Recalled:
Approximately 219 pounds

Quantity Recovered:
To Be Determined

Distribution:
Lincoln, MT and through catalog sales

Recall Classification:
Class I

Recall Notification Level:
Consumer

Press Release:
Montana Firm Recalls Beef Sausage for Potential Contamination with Microbiological Pathogens

Direct Notification Means:
The firm has notified its customers verbally and will follow-up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (612) 370-2400
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
February 18, 2006

Recall Case Number:
006-2006

[Kitchen Witch]

Tracleer (bosentan)
Audience: Cardiopulmonary healthcare professionals
[Posted 03/02/2006] Actelion and FDA notified healthcare professionals of changes to the prescribing information based on cases of hepatotoxity reported. The notification underscored the need to continue monthly liver function monitoring for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.

[March 01, 2006 ? Letter ? Actelion] [Adobe Acrobat pdf format]
[March 2006 ? Label and Medication Guide ? Actelion] [Adobe Acrobat pdf format]

[Kitchen Witch]

Classic Delight Initiates Nationwide Recall of Egg Salad on Vienna Bread Sandwiches Because of a Possible Health Risk


Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Classic Delight Initiates Nationwide Recall of Egg Salad on Vienna Bread Sandwiches Because of a Possible Health Risk
Contact:
Classic Delight Inc.
(419) 394-7955
FOR IMMEDIATE RELEASE -- St. Marys, OH -- March 6, 2006 -- Classic Delight, Inc. of St. Marys, Ohio is recalling "Egg Salad on Vienna Bread, Pilot good to go" sandwiches because the product has the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses resulting from the consumption of this product have been reported to date.
The product is labeled under the name "Egg Salad on Vienna Bread, Pilot good to go!", Net Wt. 4.50 oz., with a lot code of 5355. The individual product label identifies the product as distributed by Pierre Foods, Inc, Cincinnati, OH.
The Egg Salad sandwiches were packaged frozen as 12/4.50 oz. sandwiches per case and distributed to Pilot Travel Centers LLC located in the following states: Ohio, Wisconsin, Wyoming, Utah, Nevada, Oregon, Iowa, Montana, Kentucky, Tennessee, North Carolina, Mississippi, Arkansas, West Virginia, New Mexico, Oklahoma, South Dakota, New Jersey, Pennsylvania, Idaho, Florida, Illinois, Colorado, Georgia, New York, Texas, California, Washington, Arizona and Indiana. The frozen sandwiches are intended to be thawed and sold as a single service item at the Pilot locations.
The recall is voluntarily being conducted by Classic Delight after it was notified by the U.S. Food and Drug Administration that a random sample of this sandwich lot taken and analyzed by the Ohio Department of Agriculture was positive for Listeria monocytogenes. Classic Delight Inc. has ceased the production and distribution of this product and Pilot Travel Centers LLC. has voluntarily pulled all products as the FDA and the company continue their investigation as to what caused the problem.
Consumers who have purchased this product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-274-9828.

[Kitchen Witch]

Recall -- State Press Release
Consumer Alert: Undeclared Milk in Maizteca Mexican Bread

Contact:
Jessica Chittenden
518-457-3136

FOR IMMEDIATE RELEASE -- March 8, 2006 -- State Agriculture Commissioner Patrick H. Brennan alerted consumers today that 215 Washington St. Foods, Inc., d/b/a Maizteca Bakery, 215 Washington St., Newburgh, New York 12550 is recalling 1.5 pound packages of "Maizteca Mexican Bread" due to an undeclared milk ingredient. People who have allergies to milk may run the risk of serious or life-threatening allergic reactions if they consume this product.

The recalled "Maizteca Mexican Bread" comes in an uncoded plastic package. It was sold in New York and Connecticut.

The problem was discovered as a result of routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department's Food Laboratory personnel revealed the presence of a milk ingredient in product packages which did not declare a milk ingredient on the label.

No illnesses have been reported to date to this Department in connection with the problem.

Consumers who have purchased "Maizteca Mexican Bread" should return it to the place of purchase.

[Kitchen Witch]

Indiana Firm Recalls Frozen Stuffed Chicken Entrees Associated With Illnesses
[ ]
Recall Release CLASS I RECALL
RC-FSIS-09-2006 HEALTH RISK: HIGH
Congressional and Public Affairs
(202) 720-9113
Amanda Eamich

WASHINGTON, March 10, 2006 - Serenade Foods Division, a Milford, Ind., firm, is voluntarily recalling approximately 75,800 pounds of frozen stuffed chicken entrees that may be unhealthful and therefore unfit for food, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The recalled products must be cooked to a minimum internal temperature of 165 °F.

The raw chicken entrees, because of their frozen state, labeling, and cooked appearance, may have caused consumers to believe these raw products are pre-cooked and therefore consumers may not be cooking these products to a safe temperature. Because of these characteristics, consumers may not be following cooking instructions. The products were contaminated with Salmonella Enteritidis that causes human illness. Illnesses have been linked directly to these products through case history of the patients and through microbiological testing of both the products and affected consumers.

Salmonella Enteritidis is a serotype of Salmonella found on raw poultry in the United States. It is important for consumers to properly cook all meat and poultry products that are not fully pre-cooked during the manufacturing process. Because the recalled products are stuffed with additional ingredients, they likely take longer to cook than chicken breasts that do not contain fillings to reach a safe minimum internal temperature of 165 °F. Failure to properly cook the recalled products to a minimum internal temperature of 165 °F has led to a number of cases of salmonellosis in Minnesota.

FSIS reminds consumers to ensure that raw meat and poultry products are fully cooked before they are consumed. Using a food thermometer is the only sure way of knowing if your food has reached a high enough temperature to destroy foodborne bacteria. Cooking products from the frozen state increases the likelihood of undercooking meat and poultry products unless the minimum internal temperature is properly monitored. When appropriate, frozen products should be thoroughly and safely thawed prior to cooking.

The following products are subject to recall: [Labels]

* 6-ounce individually wrapped "MAPLE LEAF FARMS, CHICKEN BREAST with Rib Meat, SHRIMP & CRAB, Specially Cut and Shaped, Breaded Boneless Breast of Chicken with Rib Meat, Stuffed with a Shrimp & Crab Stuffing. " Each label includes the establishment number, "P-2375" inside the USDA mark of inspection. Each label also includes the production code "S5307." The products were produced on November 3, 2005.

* 4.5-pound cases of "MAPLE LEAF FARMS, CHICKEN BREAST with Rib Meat, STUFFED WITH SHRIMP & CRAB STUFFING, BREADED BONELESS BREAST OF CHICKEN WITH RIB MEAT, SPECIALLY CUT AND SHAPED, STUFFED WITH SHRIMP AND CRAB STUFFING." Each label includes the establishment number, "P-2375" inside the USDA mark of inspection. Each label also includes the production code "5307." The products were produced on November 3, 2005.

* 6-ounce individually wrapped "MAPLE LEAF FARMS, CHICKEN BREAST with Rib Meat, BROCCOLI & CHEESE, Specially Cut & Shaped, Breaded Boneless Breast of Chicken with Rib Meat, Stuffed with Broccoli, Swiss & American Cheeses, Not Pre-Cooked." Each label includes the establishment number, "P-2375" inside the USDA mark of inspection. Each label also includes the production code "B5308." The products were produced on November 4, 2005.

* 6-ounce individually wrapped "KIRKWOOD, Chicken Breast with Rib Meat, BROCCOLI & CHEESE, Breaded Boneless Breast of Chicken with Rib Meat, Specially Cut and Shaped, Filled with Broccoli and Cheese, Pre-Browned, Not Pre-Cooked." Each label includes the establishment number, "P-2375" inside the USDA mark of inspection. Each label also includes the production code "B5308." The products were produced on November 8, November 28, December 14, December 21 and December 29, 2005.


The problem was discovered by a Minnesota Department of Health and Minnesota Department of Agriculture investigation into reported foodborne illnesses related to these products. The Minnesota Department of Health contacted FSIS after receiving positive Salmonella Enteritidis test results of the products.

The frozen stuffed chicken entrees were distributed to retail establishments nationwide.

On March 22, 2006, a National Advisory Committee on Microbiological Criteria for Foods Subcommittee will discuss consumer guidelines for the safe cooking of poultry products. Safe cooking guidelines for stuffed raw chicken products covered by a partially browned crust will be addressed. FSIS has been concerned about this class of product that has been associated with illnesses in 2002 and 2005.

Consumers with questions about the recall should contact the company Consumer Hot Line at (866) 873-7589. Media with questions about the recall should contact company Communications Manager Janelle Deatsman at (800) 348-2812 extension 2846.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at (88 674-6854. The hotline is available in English and Spanish and can be reached from 10 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. "Ask Karen" is the FSIS virtual representative available 24 hours a day to answer your questions at http://www.fsis.usda.gov/Food_Safety...ion/Ask_Karen/
index.asp#Question.


USDA Recall Classifications
Class I This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
Class II This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.
Class III This is a situation where the use of the product will not cause adverse health consequences.

[Kitchen Witch]

Ho's Trading Inc. Recalls Fortune Star White Fungus

Contact:
Alvin Ho
718-622-2288

FOR IMMEDIATE RELEASE -- Brooklyn, NY -- March 13, 2006 -- Ho's Trading Inc., 1010 Dean Street, Brooklyn, NY 11238 is recalling Fortune Star White Fungus, because they contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume this product.

The recalled Fortune Star White Fungus are packed in 3 oz., uncoded bags. The products were sold nationwide.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of undeclared sulfites in Fortune Star White Fungus which did not declare sulfites on the label. The consumption of 10 milligrams or more of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date in connection with this problem.

Consumers who have purchased Fortune Star White Fungus should return it to the place of purchase. Consumers with questions may contact the company at 1-718-622-2288.

####

[Kitchen Witch]

New Jersey Firm Recalls Chicken Noodle Soup Product Due To Undeclared Allergen
[ ]
Recall Release CLASS I RECALL
FSIS-RC-10-2006 HEALTH RISK: HIGH
Congressional and Public Affairs
(202) 720-9113
Tara Balsley

WASHINGTON, March 14, 2006 - Unilever United States, Inc., of Englewood Cliffs, N.J., is voluntarily recalling approximately 36,560 pounds of chicken noodle soup due to an undeclared allergen (milk protein), the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.

The product label does not specifically state that milk, an allergen, is an ingredient.

The following product is subject to recall:

* 4.2 ounce boxes of "LIPTON® NOODLE SOUP-CHICKEN NOODLE with diced white chicken meat." Each label includes the establishment number, "P-18569" inside the USDA mark of inspection. Each label also includes one of the following best if used by dates: "APR 27 07," "APR 28 07," "APR 29 07," "MAY 02 07," "MAY 03 07," "MAY 04 07" or "MAY 05 07." Each shipping case bears the code "4100000332." Each box bears the code "413320."


[ ]
<http://www.fsis.usda.gov/images/vrule.gif>
FOOD ALLERGIES

Consumers who have a food allergy, or severe food sensitivity, should always read ingredient labels. In restaurants, they should ask whether an allergy-causing ingredient is in the food.

A food allergy occurs when the immune system reacts to a certain food, usually within minutes after the food has been consumed.

Symptoms may include throat swelling, breathing trouble or a rash.

Strictly avoiding the allergy-causing food is the only absolute way to avoid a reaction.

Several foods account for 90% of allergic reactions. They include peanuts, tree nuts (walnuts, pecans, etc.), fish, shellfish, eggs, milk, soy, and wheat.

Persons who have a severe, life-threatening food allergy should always carry, and know how to administer, prescription epinephrine.
<http://www.fsis.usda.gov/images/vrule_2.gif>
[ ]
The product was produced from February 1 through 9, 2006. The product was sold to retail establishments nationwide and shipped to military bases in the U.S.

The problem was discovered following a consumer complaint. FSIS has received no reports of illness due to consumption of these products. Anyone concerned about an allergic reaction should contact a physician.

Consumers with questions about the recall should call the Lipton® Chicken Noodle Soup toll-free recall hotline at (866) 839-7008. Media with questions about the recall should call Unilever United States, Inc., Associate Manager of Communications Sabrina Glavan at (877) 995-4483.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at (88 674-6854. The hotline is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

"Ask Karen" is the FSIS virtual representative available 24 hours a day to answer your questions at http://www.fsis.usda.gov/Food_Safety_Education/
Ask_Karen/index.asp#Question.

[Kitchen Witch]

H-E-B Issues Baby Food Recall

Contact:
Winell Herron
713-329-3923

FOR IMMEDIATE RELEASE -- San Antonio, TX -- March 15, 2006 -- H-E-B announced today that it has issued a recall of its entire H-E-B Baby Food and Mom's Organic Choice product lines. As of this afternoon, all H-E-B baby food and Mom's Organic Choice product lines was removed from shelves due to a few customer reports of pieces of glass being found inside the baby food jars of H-E-B peas, carrots and applesauce.

According to Winell Herron, H-E-B Group Vice-President of Public Affairs, there have been no reports of injuries associated with the incidents, however the company is taking the issue very seriously and taking all necessary precautions.

"Though these reports have been isolated to just a few products in the H-E-B baby food and Mom's Organic Choice line, as a company, we are committed to absolute and complete food safety. As a result of that commitment, coupled with the fact that we are dealing with a children's product, we have made the decision to pull all of our H-E-B baby food and Mom's Organic Choice products from our shelves," said Winell Herron, H-E-B Group Vice-President of Public Affairs.

Herron went on to say that H-E-B will launch a full investigation into the incidents and work closely with its H-E-B baby food suppliers to ensure all safety measures are being taken when manufacturing the product.

H-E-B is encouraging anyone who has any H-E-B baby food and/or Mom's Organic Choice product in their pantries to remove it and take it to their nearest H-E-B store for a full refund.

Customers with any questions or concerns can call H-E-B customer service at 1-800-432-3113.

[Kitchen Witch]

Sepsis and Medical Abortion Update
March 17, 2006

The Food and Drug Administration has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex). The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

The approved Mifeprex regimen for a medical abortion through 49 days? pregnancy is:

* Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once
* Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once.
* Day 14: Post-Treatment: the patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage medical abortion treatment failures.
* The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA.

These recommendations are consistent with warnings in the Prescribing Information and information for the patient in the Medication Guide. FDA also emphasizes that healthcare professionals and patients should be aware of the following:

* All providers of medical abortion and emergency room health care providers should investigate the possibility of sepsis in patients who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection more than 24 hours after taking misoprostol. To help identify those patients with hidden infection, strong consideration should be given to obtaining a complete blood count.

* FDA recommends that physicians suspect infection in patients with this presentation and consider immediately initiating treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii.

* FDA does not have sufficient information to recommend the use of prophylactic antibiotics. Reports of fatal sepsis in women undergoing medical abortion are very rare (approximately 1 in 100,000). Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, prophylactic use of antibiotics can stimulate the growth of ?superbugs,? bacteria resistant to everyday antibiotics. Finally, it is not known which antibiotic and regimen (what dose and for how long) will be effective in cases such as the ones that have occurred.

As previously provided in our July 19, 2005 Public Health Advisory, updated on November 4, 2005, the Agency is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone (Mifeprex) and misoprostol. All four cases of fatal infection tested positive for Clostridium sordellii . All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol. In addition, FDA tested drug from manufacturing lots of mifepristone and misoprostol and found no contamination with Clostridium sordellii.

We do not know whether these new deaths were caused by sepsis or, if they were, if they were caused by infection with Clostridium sordellii . However, FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), is conducting a public workshop on May 11, 2006. This scientific workshop entitled, ?Emerging Clostridial Disease,? at the CDC Conference Center, Atlanta, Georgia, is being conducted to discuss the scientific and medical circumstances associated with reports of morbidity and mortality associated with C. sordellii and C difficile infections. These reports include cases and clusters of C. sordellii toxic shock syndrome following treatment with mifepristone, C. sordellii sepsis associated with skin grafts, and rapidly fatal toxin-mediated cases of community-associated C. difficile infection. The primary goal of the workshop is to bring together scientific and public health experts to develop a draft research agenda leading to a better understanding of the virulence, pathogenesis, host factors, and non-antimicrobial risk factors contributing to those reports.

Information pertaining to Mifeprex can be found at http://www.fda.gov/cder/drug/infopag...ne/default.htm

Information pertaining to Emerging Clostridial Diseases Public Workshop can be found at http://www.fda.gov/cder/meeting/clostridia_disease.htm

[Kitchen Witch]

Frozen Specialties, Inc. Issues Nationwide Allergy Alert on Undeclared Soy in Kroger Cheese Pizza Bite Product

Contact:
Chris Overholt
419-446-6555

FOR IMMEDIATE RELEASE -- March 16, 2006 ? Frozen Specialties, Inc. Holland , OH is recalling the following lots of Kroger Cheese Pizza Bites because they contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. The products are not harmful unless the consumer is allergic to soy. The recall applies only to products with a retail UPC Code of 11110-82334 and Sell By dates of FEB 17/07, MAR 03/07, Mar 06/07, Mar 08/07 and Mar 14/07. The Sell By code is printed on each package on the right side of the back panel near the package seal. This recall applies only to Kroger Cheese Pizza Bites packaged in 20.0 oz./40 count retail packages.

The Kroger Cheese Pizza Bites were sold at Kroger, Dillon, King Soopers, Frys, Smiths and Jay C stores and also the Food 4 Less stores in California , Nevada and Chicago area.

No illnesses have been reported to date.

The recall was initiated after it was discovered that an ingredient containing soy was not listed in the ingredient statement on package.

Consumers who are allergic to soy are advised not to consume the Kroger Cheese Pizza Bites and return the product to store where purchased for refund. Consumers with questions may contact Kroger's at 800-632-6900.

Frozen Specialties, Inc. is taking this voluntary action to ensure the safety of its consumers and is working closely with the U.S. Food and Drug Administration in the recall process. Frozen Specialties, Inc. is committed to the quality and safety of its products and sincerely regrets any inconvenience that this incident may have caused.

[Kitchen Witch]

Pinnacle Foods Group Inc. Issues Allergy Alert on Brownie Mix

Contact:
Mr. Kelley Maggs
(973) 541 - 6640

FOR IMMEDIATE RELEASE -- March 17, 2006 -- Pinnacle Foods Group Inc. of Mountain Lakes, NJ is recalling a limited production run of Duncan Hines Double Fudge Brownie mix, which was manufactured by a co-packer for distribution by Pinnacle, due to an undeclared ingredient (walnuts). This recall applies only to the following products: "DUNCAN HINES® CHOCOLATE LOVER'S DOUBLE FUDGE BROWNIES" with the lot code listed below, which were sold at Wal*Mart stores located ONLY in the following 12 states: Oklahoma, Texas, Kansas, Arkansas, Tennessee, North Carolina, South Carolina, Kentucky, Virginia, West Virginia, Indiana and Georgia.

These cartons may contain ?Walnut Brownie' mix rather than the ?Double Fudge Brownie' mix and could therefore contain nuts not listed on the carton. People who have an allergy or severe sensitivity to walnuts may run the risk of a serious or life-threatening allergic reaction if they consume this product.

This voluntary recall was initiated after the Company received call from a consumer informing the Company that the "DUNCAN HINES® CHOCOLATE LOVER'S DOUBLE FUDGE BROWNIES" he purchased actually contained a walnut brownie mix. There have been no reports of illness as a result of this incident.

Production Code information is as follows:

Retail Carton UPC Code: 6-44209-33247-2
Carton Description: "DUNCAN HINES® CHOCOLATE LOVER'S DOUBLE FUDGE BROWNIES"
BEST IF USED BY code located on bottom of carton: JAN-09-07

If you are allergic to or have a severe sensitivity to treenuts, you should not consume this product. Please return the product to the store where purchased for a full refund.

If you are not allergic to nuts, this product is safe to eat.

This announcement applies only to the "DUNCAN HINES® CHOCOLATE LOVER'S DOUBLE FUDGE BROWNIES and does not apply to any other Duncan Hines products sold by Wal*Mart in the above 12 states.

Consumers with questions may contact the Company at 1-800-554-5680.

The Food and Drug Administration has been made aware of this recall.

[Kitchen Witch]

Brach?s Confections, Inc. Issues Allergy Alert on Undeclared Almonds in Sam?s Choice? Belgian Milk Chocolate Bars

Contact:
Julie Daniels
972-930-3770

FOR IMMEDIATE RELEASE -- March 21, 2006 -- Brach's Confections, Inc. of Dallas, Texas is recalling a limited production lot of Sam's Choice Belgian Milk Chocolate Bars, because they may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

Sam's Choice Belgian Milk Chocolate Bars are distributed by Wal-Mart stores nationwide.

The Sam's Choice Belgian Milk Chocolate bar is a 7 ounce (200 gram) bar wrapped in a purple paper outer wrap. The upper right corner of the back panel of the bar displays a "Best By:" marker featuring code D2551A2 December 20, 2006.

No illnesses have been reported.

The recall was initiated after it was discovered that product containing almonds was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the problem was caused by an isolated, temporary breakdown in the company's production and packaging processes.

Consumers who have purchased a Sam's Choice Belgian Milk Chocolate Bar with this code date are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-283-6303.

[Kitchen Witch]

North Country Spring Water, Ltd. Recalls Entire Production of Bottled Water Products Due to Potential Health Concerns

Contact:
Roger Jakubowski
(51 834-9400

FOR IMMEDIATE RELEASE -- Port Kent, NY, March 24, 2006 -- North Country Spring Water, Ltd. of Port Kent ( Essex County ) New York is voluntarily recalling all of its bottled water products because the bottled water may be contaminated with total coliform bacteria and diatoms (algae). The New York State Department of Health has confirmed coliform bacteria and diatoms in some samples of bottled water produced by North Country Spring Water, Ltd. Coliform bacteria are naturally present in the environment and are used as an indicator that other, potentially-harmful, bacteria may be present. The presence of coliform bacteria in bottled water is a violation of the New York State Sanitary Code. Coliform bacteria may indicate the presence of other potential contamination. The presence of diatoms can be an indication that untreated or partially treated surface water is contaminating the source water used in the bottling process.

North Country Spring Water, Ltd. bottled water products were distributed wholesale in New York , Vermont and New Jersey where the bottled water was sold to consumers through retail stores and direct delivery.

Due to the fact that production date codes were omitted from the bottled water containers, all bottled water products with the New York State Health Department certification number 078( NYSHD Cert. #078 ) are being recalled. Bottled water products with the following labels and container sizes are associated with NYSHD Cert. #078 (Note: This recall is only associated with those labels that bear the NYSHD Cert. #078 ):

* North Country 100% Natural Spring Water - 8 FL. OZ. 237 ml, 128 FL. OZ. (1 GAL.) 3.78 L
* Hidden Spring Natural Spring Water - 1 GALLON
* Price Chopper Desert Spring Water - 1 GAL (3.78 L), 2.5 GAL (9.46 L)
* Loyola Springs 100% Natural Spring Water - 128 FL OZ (1 GAL.) 3.78 LITER
* Hannaford Natural Spring Water - 1 GAL. (3.78 L)
* Famous Famiglia " New York Water ... The Best Pizza." TM - 1 GALLON
* Western Beef Natural Mountain Spring Water - 2.5 Gallons (9.47 L)

No illnesses have been confirmed. Individuals who have consumed this water and have health concerns, or gastrointestinal symptoms, or who are immuno-compromised should consult with their health care provider.

The recall was initiated after it was discovered that products were contaminated with total coliform bacteria and diatoms. Subsequent investigation indicates the problem may have been caused by a potential surface water contamination event at the water source and/or a temporary breakdown in the company's filtration system.

Consumers who have purchased bottled water products with the NYSHD Cert. #078 are urged to return the bottled water to the place of purchase for a full refund. Consumers with questions may contact the company at (51 834-9400.

[Kitchen Witch]

Anthony-Thomas Candy Company Issues Allergy Alert on Undeclared Egg Whites in Both 6 oz. & 12 oz Size Filled Easter Eggs

Contact:
Anthony Thomas Candy Company
1-877-226-3921

FOR IMMEDIATE RELEASE -- Columbus, OH -- March 28, 2006 -- Anthony-Thomas Candy Company, Columbus, OH is recalling 6 oz and 12 oz packages of Filled Easter Eggs because they may contain undeclared egg whites, yellow #5 and yellow #6. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses have been reported to date.

The Filled Easter Eggs were distributed through retail stores between January 27, 2006 and March 27, 2006 in the following states: AL, CO, CT, IL, IO, MA, MI, MS, NY, OH, TN, TX, WV, WI.

The following flavors are included in the recall: Coconut Cream, Peanut Butter, Butter Cream, Fruit and Nut, Chocolate Fudge, Chocolate Fudge Pecan, and Maple Walnut Fudge with production code numbers from 6027 to 6083.

The product is packaged in a cardboard package with a clear cellophane top panel in which the filled egg can be viewed.

The recall was initiated after it was discovered that product containing egg was distributed in packaging that did not reveal the presence of egg. The egg whites are an ingredient in the decorative flowers on these products.

Distribution of these products has been suspended until the company and FDA are certain that the problem has been corrected.

Consumers who purchased Anthony-Thomas Chocolates brand 6 oz and 12 oz Filled Easter Eggs between January 27, 2006 and March 27, 2006 are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company toll free at 1-877-226-3921.

[Kitchen Witch]

Nestlé Country Creamery Ice Cream being Recalled in Texas
Ice Cream May Contain Egg Not Identified On The Label

Contact:
Dori Sera Bailey
(510) 601-4241

FOR IMMEDIATE RELEASE -- Oakland, Calif., March 28, 2006 --- Two flavors of Nestlé Country Creamery Ice Cream purchased from Wal-Mart stores in Texas are being recalled because the ice cream may contain egg not identified on the label. The Nestlé Country Creamery flavors being recalled are Toll House® Chocolate Chip and French Vanilla.

The potentially affected cartons of Nestlé Country Creamery Toll House® Chocolate Chip 1.75-quart and Nestlé Country Creamery French Vanilla 1.75-quart have a "Best If Purchased By 11/10/06" date. The date can be found on the bottom of the carton. Only 43 mislabeled cartons are believed to be in the marketplace. The affected cartons, which pose no risk to those without egg allergies, were sold only in Wal-Mart stores in Texas.

No other Nestlé Country Creamery ice cream products are affected.

Only individuals who have an allergy or severe sensitivity to egg may run the risk of serious or potentially life-threatening allergic reaction if they consume this product. People with an egg allergy or sensitivity to eggs should not consume the ice cream and should immediately dispose of the product. For most consumers, there is no quality or safety issue with the ice cream.

No consumers have reported symptoms of allergic reaction. Dreyer?s Grand Ice Cream, which manufactures Nestlé Country Creamery, is working with the U.S. Food and Drug Administration in implementing this voluntary product recall and is investigating the incident. Dreyer?s is also working with the Food Allergy and Anaphylaxis Network to alert consumers in the Texas areas.

Consumers who have purchased the ice cream in question should call the Nestlé Country Creamery Consumer Call Center at 1 888 837-4438, for a full refund.

Dreyer?s Grand Ice Cream manufactures and distributes ice cream and frozen snacks across the United States.

[Kitchen Witch]

Ossur Announces Voluntary Recall of Certain Models of the Total Knee®

Contact:
United States & Canada: 800 233 6263
Europe: +31 499 462 840
Scandinavia: +46 1818 2200
Asia-Pacific: +61 2 9630 9206
Other countries: +354 515 1342

FOR IMMEDIATE RELEASE --Reykjavik, Iceland -- March 29th, 2006 -- Ossur hf. (ICEX: OSSR) today announced a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee® prosthetic device. The company's initiation of the recall, effective immediately, is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee.

At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company. To date, the incidence of actual product failures within the recalled knees is less than one percent (1%).

The serial numbers of the affected knees, which were ordered from June 7th, 2005 to present, have been identified. The O & P facilities who have provided a Total Knee that contains the affected serial number will receive a letter and a phone call with the proper replacement procedure in the next few days.

In addition, Ossur has temporarily suspended sales and shipments of Total Knees until further notice. To expedite this process in the consideration of both its customers and patients, the implementation of a replacement program will be effective immediately.

"We take the issue of patient safety very seriously," said Jon Sigurdsson, president and chief executive officer of Ossur. "We instituted this recall immediately, upon learning of the faulty pins, because we believe that the patient's wellbeing is our first priority. In addition, we are taking measures to guarantee the quality and safety of the replacement knees."

Ossur has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision to implement this recall.

Ossur will continue to provide regular and frequent updates as more information becomes available. You may also access the company website at www.ossur.com for this information, in real time.

If you have additional questions, you may contact Ossur at the following numbers:
United States & Canada: 800 233 6263
Europe: +31 499 462 840
Scandinavia: +46 1818 2200
Asia-Pacific: +61 2 9630 9206
Other countries: +354 515 1342

[Kitchen Witch]

Diastat AcuDial (diazepam rectal gel)
Audience: Neurologists, pharmacists and consumers
[Posted 03/30/2006] Valeant Pharmaceuticals International and FDA notified healthcare professionals of complaints the company received concerning small cracks at the base of the plastic tip of the applicators with resulting leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. Diastat is indicated for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Complaints were received for the Diastat AcuDial Applicators 10mg and 20mg product twin packs.

Healthcare professionals should advise patients using the product of this issue and to return any product with a cracked tip to their pharmacy for immediate replacement. Pharmacists should inspect all product on their shelves and contact Rx Hope at 1-800-511-2120 or www.Rxhope.com for replacement product. Emergency support should always be available in case seizures are not controllable with Diastat AcuDial.

[March 30, 2006 - Drug Information Page - FDA]
[February 21, 2006 - Dear Doctor Letter - Valeant]
[February 21, 2006 - Dear Pharmacist Letter - Valeant]

[Kitchen Witch]

Davol/Bard Composix Kugel Mesh Patch
Audience: Surgeons, surgical service personnel and hospital risk managers
[UPDATE 3/31/2006] Davol/Bard and FDA notified healthcare professionals of an expanded recall of this product to include Oval, Large Oval and Large Circle Kugel mesh patches. Bard also issued letters to hospitals and health care professionals providing updated Instructions for Use, clarifying the proper insertion technique and offering supplemental patient management information.

[Posted 03/02/2006] Bard/Davol and FDA notified healthcare professionals of a class 1 recall of Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

[March 31, 2006 ? Recall Notice ? FDA]
[March 24, 2006 ? Dear Chief of Surgery letter ?Davol/Bard]
[March 24, 2006 ? Dear Hospital Administrator letter ?Davol/Bard]
[March 24, 2006 ? Dear Distributor letter ?Davol/Bard]

[March 02, 2006 ? Previous Recall Notice ? FDA]

[Kitchen Witch]

Dagoba Organic Chocolate Recalls "Eclipse 87%," "Los Rios 68%," And "Prima Matera 100%" Dark Chocolate Products Because of High Lead Levels

Contact:
Melissa Schweisguth
(541) 482-2001, xt 17

FOR IMMEDIATE RELEASE --Ashland, OR -- March 31, 2006 -- Dagoba Organic Chocolate of Ashland, OR is recalling their "ECLIPSE 87%," "LOS RIOS 68%," and "PRIMA MATERA 100%" dark chocolate products in retail and bulk formats because they contain high levels of lead.

If a child or fetus is exposed to high lead levels on a routine basis (daily for a period of several weeks), permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems. In addition, sustained consumption of products containing high lead levels can produce lead poisoning which has a number of symptoms including anemia, neurologic effects such as ataxia and irritability, constipation, muscular weakness, and chronic nephritis.

The products were distributed nationally through wholesale food distributors and through stores that sell organic, natural and/or specialty foods, as well as via select internet sites.

The six products are:

1) Dagoba Organic Eclipse 87% Extra Dark, Size: 2 oz bar
Lot Codes:
20061122
20061130
20061201
20061206
20061213
20061214
20061219
20061227
20070103
20070116
20070130
20070213
20070220
20070227
20070306
20070313

2) Dagoba Organic Los Rios 68% - Ecuador Arriba, Size: 2 oz bar
Lot Codes:
20070213
20070223
20070323

3) Dagoba Organic Prima Materia 100% - Ecuador Arriba, Size: 2 lb brick
Lot Code:
20070109

4) Dagoba Organic Los Rios Choco Drops 68% - Ecuador Arriba Nacional, Size: 5 lb foil bag
Lot Code:
20070222

5) Dagoba Organic Los Rios 68% - Ecuador Arriba Nacional, Size: 25 lb bag
Lot Code:
310240498

6) Dagoba Organic "Eclipse Broken Bars" Forest Grown Organic Extra Dark Chocolate, Size: 1.5 lb bulk bags
Lot Codes:
All

No documented illnesses associated with these products have been reported to date.

The recall was the result of a routine sampling program by the company which revealed that the finished products contained high levels of lead. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem. Dagoba Chocolate is committed to rectifying this issue and ensuring that it does not occur again.

Consumers who have purchased these products should return them to the place of purchase for a full refund.

Consumers with questions are encouraged to visit the company's website at http://www.dagobachocolate.com/recall. They may also contact the company toll-free at 1-800-393-6075 or via email at recall@dagobachocolate.com.

[Kitchen Witch]

FDA's Advisory for Users of Diastat AcuDial Delivery Systems

The Food and Drug Administration is advising patients with epilepsy and their care givers of a potential hazard caused by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems. These cracks can result in the leakage of gel during its application, which results in the patient not getting enough of the medicine to control seizures. Caregivers for these patients are advised to call their local emergency response center or 911 for help in any seizure emergency.

Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to a life-threatening condition in which seizures are continuous. The drug is typically administered by family members or caregivers at home.

"FDA is working with the manufacturer to resolve this issue as quickly as possible, as this is the only product approved to treat patients with this condition at home," said Dr. Steven K. Galson, Director of FDA's Center for Drug Evaluation and Research (CDER). "However, with routine inspection of the product, patients will be able to get the correct dosage administered for treatment."

Patients and their caregivers should immediately and carefully examine their Diastat AcuDial pre-filled syringes for cracks in the applicator tip, which can be easily seen. These inspections should be performed at least once a month. It is very important that the CAP NOT BE REMOVED during inspection. For detailed directions on how to look for cracks on the applicator tip without removing the cap go to www.diastat.com , and click on the Alert box. If you do not have internet access, or if you would like more advice regarding the inspection, call Valeant Pharmaceuticals at 1-877-361-2719.

Syringes with cracks should be returned to the pharmacist and exchanged for new ones at no cost. There have been more than 100 reports of cracked applicator tips in the 10mg and 20mg syringes. The frequency of cracks has varied, but as many as six percent of syringes in some lots have shown cracks.

The manufacturer, Valeant Pharmaceuticals of Costa Mesa, CA, has sent letters to pharmacists asking them to inspect the product prior to dispensing, and inform patients about the need to routinely inspect the syringes. The manufacturer has sent similar letters to physicians who treat patients with epilepsy.

The manufacturer believes that it has identified the source of the defects, but its new version of this product will not reach the market until June or July. Until then, current syringes will continue to be sold because there are no other available treatments for this condition that can be administered at home.