Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets USP 15 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
FDA Drug Recalls
17,898 recalls, newest first
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 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 Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class I · High risk Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class II · Moderate risk Ongoing
Artificial Tears
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class I · High risk Ongoing
Artificial Tears
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.