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
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.