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potential for contamination with listeria monocytogenes
Product mislabeled. The back label states Organic Cashews. The front product label states Wegmans Organic unsalted dry roasted almonds. The front label is correct label for this product.
Undeclared allergens (wheat) on label, incorrect label was placed on product
Product contains undeclared milk and soy.
Small pieces of plastic broken tray in the product.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Milk not listed in the ingredients or included in parentheses after American Cheese.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
CGMP Deviations; product intended for quarantine was inadvertently distributed
Undeclared milk
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.