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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