Recalls / Class I
Class ID-0833-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Lamotrigine
- Generic name
- Lamotrigine
- Active ingredient
- Lamotrigine
- Route
- Oral
- NDCs
- 51672-4130, 51672-4131, 51672-4132, 51672-4133
- FDA application
- ANDA078525
- Affected lot / code info
- Lot #: 331771, Exp. June 2021
Why it was recalled
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico.
Timeline
- Recall initiated
- 2019-12-20
- FDA classified
- 2020-02-07
- Posted by FDA
- 2020-02-19
- Terminated
- 2024-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0833-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.