Clopidogrel Tablets USP
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Yes — there is an active recall. 1 ongoing FDA recall mention Clopidogrel (7 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clopidogrel. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Presence of foreign matter
Reason Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Reason Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Reason LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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