Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP 7.5 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
FDA Drug Recalls
14,801 recalls, newest first
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 III · Low risk Terminated
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class III · Low risk Terminated
Bd-102 Nf
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-200 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH- 102 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH- 101 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug