Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Indust...

FDA Recall #D-0833-2020 — Class I — December 20, 2019

Recall #D-0833-2020 Date: December 20, 2019 Classification: Class I Status: Terminated

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.

Recalling Firm

Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Distribution

Nationwide in the U.S. and Puerto Rico.

Code Information

Lot #: 331771, Exp. June 2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

Back to All Drug Recalls