FDA Recall D-0833-2020
Taro Pharmaceuticals U.S.A., Inc. · Hawthorne, NY
Class I — life-threatening Terminated 1526 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Reason for recall
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Recall record
- Recall number
D-0833-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the U.S. and Puerto Rico.
- Recall initiated
- 2019-12-20
- Classified by FDA Center
- 2020-02-07
- FDA published
- 2020-02-19
- Terminated
- 2024-02-23
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Firm location
- Hawthorne, NY
Drug identification
- Brand name(s)
- LAMOTRIGINE
- Generic name(s)
- LAMOTRIGINE
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
51672-4130, 51672-4131, 51672-4132, 51672-4133- Route(s)
- ORAL