Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16

FDA recall notice · announced February 7, 2018 · International Laboratories

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16

Reason for recall

LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.

Notes

Distribution: Nationwide within the US
Lot/code information: Lot #: 117099A, Exp. 08/19
Quantity: 218772 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.