360 recalls · Class II, newest first
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Lack of Assurance of Sterility: due to a quality control process deviation
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Subpotent Drug
CGMP Deviations: sterile water not used for production
CGMP Deviations: sterile water not used for production
CGMP Deviations and Presence of Particulate Matter: Glass
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
cGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
Failed Stability Specifications