Class I — High risk. Reasonable probability of serious harm or death.
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
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 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…
Reason Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.