15 recalls, newest first
Reason Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and…
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and…
Reason Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason Presence of foreign tablets/capsules
Reason Lack of Assurance of Sterility: due to a quality control process deviation
Reason Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Reason Lack of Assurance of Sterility
Reason Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet