Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements Recalled due to Potential Salmonella Contamination

The US FDA informs Consumers and Healthcare Professionals that Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements are recalled because they might contain the bacteria salmonella which can cause serious, and sometimes fatal, infections in young children and people with weakened immune system.

Background of Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements

Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements, by Standard Process Inc., are tablets which were distributed in 60 cc and 200 cc amber glass bottles with the indication Best Used By dates (BUB) of 5/13 on both bottles and boxes.

The products were sold via healthcare professionals.

FDA Alert on Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements

A routine FDA record inspection revealed that ingredients in these products might contain salmonella. The bacteria may cause serious infections which can be fatal especially in young children, elderly and people with weakened immune system.

The affected lots are:

• Cataplex ACP (Product number 0700 and 0750) Lot 114
• Cataplex C (Product number 1650 1655) Lot 114
• Pancreatrophin PMG (Product number 6650) Lot 114

FDA Recommendation on Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements

“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.”

Contacting the FDA to report cases with Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements

In case of detection of adverse events or side effects related to the use of Cataplex ACP, Cataplex C and Pancreatrophin PMG Dietary Supplements, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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