Drug product
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
D-0472-2018
Product summary
- Event
- Event 78913
- Status
- Terminated
- Classification
- Class I
- Quantity
- 218772 bottles
- Official record key
drug-enforcement:D-0472-2018
Official wording
Reason: LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Code information: Lot #: 117099A, Exp. 08/19
Distribution pattern: Nationwide within the US
Derived failure modes
-
Labeling or packaging
LABELING: LABEL MIX-UP