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.
Standard Process Issues Voluntary Recall of Three Supplements Because of Possible Health Risk
Standard Process Inc.
FOR IMMEDIATE RELEASE - June 29, 2012 - Standard Process Inc. of Palmyra, WI 53156 is voluntarily recalling the following 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
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.
Standard Process has provided information on this voluntary recall to all distributors and health care professionals who purchased these specific lots via telephone calls and mailings. The products were sold to consumers through health care professionals.
This recall resulted during a routine FDA record inspection which revealed that one of the ingredients used in these products potentially contained the bacteria. The company has ceased distribution of the product lots in question and is recalling them.
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.
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. Health persons infected with Salmonella often exprerience 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.
Standard Process has not received any reports of illness related to these products. In addition, Standard Process, which has a complete microbiological laboratory on their premises, has tested retained samples of these products for Salmonella. In all instances, Salmonella has been tested for and confirmed absent