FDA Recall D-0102-2018
International Laboratories, Inc. · St Petersburg, FL
Class I — life-threatening Terminated 633 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Reason for recall
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Recall record
- Recall number
D-0102-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S.A. nationwide and Puerto Rico
- Recall initiated
- 2017-08-07
- Classified by FDA Center
- 2017-12-01
- FDA published
- 2017-12-13
- Terminated
- 2019-05-02
- Recalling firm
- International Laboratories, Inc.
- Firm location
- St Petersburg, FL