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.