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Cataplex ACP, Cataplex C, and Pancreatrophin PMG Dietary Supplements: Recall - Potential for Contamination With Salmonella
AUDIENCE: Consumer, Healthcare Professional
ISSUE: Standard Process and FDA notified consumers and healthcare professionals of a recall of three dietary supplements due to potential Salmonella contamination:
- Cataplex ACP (Product number 0700 and 0750) Lot 114
- Cataplex C (Product number 1650 1655) Lot 114
- Pancreatrophin PMG (Product number 6650) Lot 114
This recall resulted during a routine FDA record inspection which revealed that one of the ingredients used in these products potentially contained the bacteria. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
BACKGROUND: The products, all tablets, were distributed in 60 cc and 200 cc amber glass bottles with Best Used By dates (BUB) of 5/13 indicated on both the bottles and the boxes. No other products or lot numbers are affected. The products were sold to consumers through health care professionals.
RECOMMENDATION: Consumers who have purchased any of these three products with specific lot codes of L114 are urged to return it to the place of purchase for a full refund. Consumers and health care professionals with questions can contact Standard Process Inc. at 866-397-3237.
- 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.
Read the MedWatch safety alert, including links to the Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310334.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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