Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
Docetaxel Injection USP
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Class III · Low risk
Montelukast sodium tablets
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class II · Moderate risk
Fluconazole Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Fluconazole Tablets
Failed Dissolution Specifications
Class III · Low risk
Dye Free Allergy Softgel Gelatin Capsule
Subpotent
Class III · Low risk
Diphenhydramine HCl 25 mg
Subpotent
Class II · Moderate risk
Alfuzosin Hydrochloride Extended-release Tablets
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class III · Low risk
Donepezil HCl tablets
Supotent: Out of Specification result for assay test during routine stability testing.