436 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
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Subpotent Drug
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Reason CGMP Deviations: sterile water not used for production
Reason CGMP Deviations: sterile water not used for production
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Reason Cross contamination with other products
Reason Cross contamination with other products
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Reason Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.