Taro Pharmaceuticals U.S.A. has issued to recall of a lot of Lamotrigine 100 mg tablets owing to cross-contamination with a trace of another drug substance – Enalapril Maleate.
Lamotrigine is indicated for the treatment of epilepsy and bipolar disorders.
The US pharmaceutical manufacturer is recalling Lot # 331771, which has an expiration date June 2021 and has 100 Lamotrigine tablets in each bottle. The recall, which is to the consumer level, is for white plastic bottles bearing the label NDC 51672-4131-1.
Taro Pharmaceuticals uses Enalapril Maleate to manufacture another drug product at the same facility where it produces Lamotrigine tablets.
The pharmaceutical manufacturing company said that the affected Lamotrigine 100 mg bottles were distributed to wholesale distributors across the US during 23-30 August 2019. The wholesale customers could have further distributed the contaminated Lamotrigine tablets to retail pharmacies for prescription dispensing to patients.
The US pharmaceutical manufacturer stated: “Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall.
“Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with FDA regulatory requirements.”
Taro Pharmaceuticals has advised consumers having any quantities of the recalled Lamotrigine 100 mg Tablets, Lot # 331771, to stop using them and return it to the pharmacy that sold it. It has asked retailers, pharmacies, and distributors to stop distributing or selling the recalled product and return them to the company.