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Protein supplement fails to declare allergen: milk
Protein supplement fails to declare allergen milk
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.
In cooperation with the FDA warning to not consume mangoes from Agricola Daniella, Mexico. FreshLine of Indianapolis, Indiana, has initiated a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes due to the potential risk that the mangoes may contain Salmonella.
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.