Class II · Moderate risk Terminated
Dofetilide Capsules 500 mcg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dofetilide Capsules 250 mcg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Dofetilide Capsules
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Daptomycin for Injection 500 mg per vial
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Daptomycin for Injection 350 mg/vial
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Clopidogrel Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP 30 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP 15 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP 7.5 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP 80 mg* Rx Only
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP 40 mg* Rx Only
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Levothyroxine Sodium Tablets
Reason Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II · Moderate risk Terminated
Abelcet
Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class II · Moderate risk Terminated
Posaconazole Delayed-Release Tablets
Reason Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug