358 recalls · Class II, 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 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 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 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 CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Subpotent Drug
Reason CGMP Deviations: sterile water not used for production
Reason CGMP Deviations: sterile water not used for production
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.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Reason cGMP Deviations
Reason Failed Dissolution Specifications
Reason CGMP Deviations
Reason Failed Stability Specifications
Reason Failed Stability Specifications
Reason Subpotent Drug: Out of specification for assay