PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: February 19, 2020 Initiated: December 20, 2019 #D-0833-2020

Product Description

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.

Details

Distribution
Nationwide in the U.S. and Puerto Rico.
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by Taro Pharmaceuticals U.S.A., Inc..
Why was this product recalled?
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Critical. Recall number: D-0833-2020.