FDA Recall D-0472-2018
International Laboratories, LLC · Seminole, FL
Class I — life-threatening Terminated 854 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0472-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide within the US
- Recall initiated
- 2018-01-04
- Classified by FDA Center
- 2018-02-20
- FDA published
- 2018-02-07
- Terminated
- 2020-05-07
- Recalling firm
- International Laboratories, LLC
- Firm location
- Seminole, FL