BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
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Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
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…
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
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…
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.