FDA recall D-0472-2018

International Laboratories, LLC · Class I · 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

Reason for recall

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

Distribution

Nationwide within the US

Key facts

Status
Terminated
Initiation date
2018-01-04
Report date
2018-02-07
Termination date
2020-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Seminole, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2018