Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: recalling drug products following an FDA inspection.
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their 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…
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.
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