Class II · Moderate risk
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
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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.
Class III · Low risk
Avicel PH- 101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk
Posaconazole Delayed-Release Tablets
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug