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Standard Process Issues Voluntary Recall of Three Supplements Because of Possible Health Risk

By Pharmaceutical Processing | June 30, 2012

 

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.

 

 

Contact:

Consumer:

Standard Process Inc.

866-397-3237 

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

 

##

SOURCE

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