Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination

[Posted 10/20/2014]

AUDIENCE: Consumer, Rheumatology

ISSUE: AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of 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. A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella.

BACKGROUND: Product from this lot was sold to consumers through the internet during the period of February through August 2014. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16.

RECOMMENDATION: Any consumer who purchased product with the lot number and expiration date above should dispose of it immediately and may request a refund by calling (866) 758-7222, Monday through Friday, 9:00 am – 5:00 pm (Central). If you have consumed the product and are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/17/2013 - Press Release - AMS Health Sciences, LLC]