December 2019 FDA Recall Lamotrigine by Taro Pharmaceuticals U.s.a., Inc.
D-0833-2020 - Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
This Class I drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on December 20, 2019 for the product Lamotrigine. The FDA reported the reason for recall as cross contamination; lamotrigine tablets 100 mg usp was contaminated with enalapril maleate.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0833-2020
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
12-20-2019
02-19-2020
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S. and Puerto Rico.
02-23-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 331771, Exp. June 2021
