FDA recall D-0833-2020

Taro Pharmaceuticals U.S.A., Inc. · Class I · drug

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.

Distribution

Nationwide in the U.S. and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2019-12-20
Report date: 2020-02-19
Termination date: 2024-02-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0833-2020