PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 7, 2018 Initiated: January 4, 2018 #D-0472-2018

Product Description

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.

Details

Units Affected
218772 bottles
Distribution
Nationwide within the US
Location
Seminole, FL

Frequently Asked Questions

What product was recalled?
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16. Recalled by International Laboratories, LLC. Units affected: 218772 bottles.
Why was this product recalled?
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2018. Severity: Critical. Recall number: D-0472-2018.