August 27, 2012
WHITEHALL, Pa.Protica Inc. has voluntarily issued a recall of several of its protein products after finding they are contaminated with bacteria known to cause life-threatening illness or death. The recall includes specific lots of Protein to Go Milk Chocolate Shake (2.5oz bottle), Protein to Go French Vanilla Latte (2.5oz bottle), Nutritional Resources Protein Wave gelatin (6oz cup) and Body Choice Protein Shots (3oz vial). The company said the recall was prompted after an investigation of the company's processing controls revealed contamination with Clostridium botulinum, a gram-positive, spore-forming bacterium that is heat-resistant during processing and can release potent neurotoxins, several of which can cause human botulism.
The products are sold nationally through retail and direct mail channels. The company warned consumers not to use the product even if it does not look or smell spoiled. It noted botulism, a potentially fatal form of food poisoning, can cause symptoms such as general weakness, dizziness, double-vision and trouble with speaking or swallowing; difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. No illnesses have been confirmed to date, but Protica advised people experiencing these problems to seek immediate medical attention.
Protica received a warning letter back in April 2012 for several failures related to both food and deitary supplement GMPs (good manufacturing practices), including failure by Protica quality personnel to reject product when levels of the bacterium Staphylococcus Aureus were found to be above specifications.
More detailed information on the recall and the affected product lots and sale dates is available at the FDA Recall website.
For more information on how to better monitor and control microbes in the manufacturing environment, check out INSIDER's recent feature: Compliance and Microbial Identification , by Christine Farrance, Ph.D., Accugenix.
Also check out the recent INSIDER webinar Overcoming GMP Challenges ; Charting a Path to a Successful GMP Inspection, and consider the upcoming GMP Training at SupplySide West trade show, held in Las Vegas in early November.
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