Class II · Moderate risk
Dofetilide Capsules
CGMP Deviations: recalling drug products following an FDA inspection.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Daptomycin for Injection 500 mg per vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 350 mg/vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Clopidogrel Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 30 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 15 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 7.5 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 80 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II · Moderate risk
Abelcet (Amphotericin B Lipid Complex)
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class III · Low risk
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class III · Low risk
Bd-102 Nf
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH- 102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.