U.S. Food and Drug Administration

 FDA Press Release,  May 16, 2007

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.

NBTY, Inc. Conducts Nationwide Recall of Shark Cartilage Capsules Because of Possible Health Risk

-- May 16, 2007 -- NBTY, Inc. of Bohemia, NY, is recalling 3 lots of Shark Cartilage Capsules manufactured in 2004 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Shark Cartilage Capsules were distributed to consumers through mail orders, internet orders, and retail stores throughout the United States.

The Shark Cartilage Capsules were packaged for various NBTY divisions and sold under the following labels, lots, and codes:

• Puritan's Pride brand Shark Cartilage Capsules, Product No. 6580, 100 Capsule Size - UPC 74312 16580 1, Lot Nos. 64950 (expiration date 8/08), 64951 (expiration date 9/08), and 66293 (expiration date 1/09);
• Good and Natural brand Shark Cartilage Capsules, Product No. 6580, 100 Capsules, UPC 74312 46580 2, Lot No. 64951 (expiration date 9/08);
• Nature's Bounty brand Shark Cartilage Capsules, Product No. 6581, 30 Capsules + 30 Free Size – UPC 74312 06581 1, Lot Nos. 64950 (expiration date 8/08), 64951 (expiration date 9/08) and 66293 (expiration date 1/09);
• Natural Wealth brand Shark Cartilage Capsules, Product No. 6581, 30– UPC 74312 86581 1, Lot No. 64950 (expiration date 8/08),
• Physiologics brand Shark Cartilage Capsules, Product No. 55131, 100 Capsules – UPC 16963 55131 1, Lot No. 64951, expiration date 9/08
• Rexall Sundown brand Shark Cartilage Capsules, Product No. 6635, 50– UPC 30768 06635 2, Lot Nos. 64951 (expiration date 9/08) and 66293 (expiration date 1/09);
• Vitamin World brand Shark Cartilage Capsules, Product No. 6580, 100 Capsule Size – UPC 74312 76580 3, Product No. 6582, 200 Capsule Size – UPC 74312 76582 7, Product No. 6585, 400 Capsule Size – UPC 74312 76585 8, Lot Nos. 64950 (expiration date 8/08), 64951 (expiration date 9/08), and 66293 (expiration date 1/09)

No illnesses have been reported to date.

This issue was discovered during routine testing of the product. Testing on additional batches of Shark Cartilage did not show any evidence of contamination.

Customers may return product back to the place of purchase for a full refund. Customers may also contact the company with questions and to obtain information on how to return the product at 1-800-217-7668.

This advisory was prepared by the FDA Office of Public Affairs.