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Presence of foreign substance: plastic-like substance.
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Presence of Foreign Substance: metal in tablet
Failed Impurities/Degradation Specifications
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Presence of Particulate Matter: Potential for black particulates in the drug product.
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Discoloration: Dotted and yellow spots on tablets
Failed Release Testing: Out of specification for particulate matter test.
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Out of specification for assay
Failed Dissolution Specifications