FDA MedWatch - Lamotrigine Tablets USP, 100 mg by Taro Pharmaceuticals: Recall

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-lamotrigine-tablets-usp-100-mg-100?utm_campaign=FDA%20MedWatch%20-%20Lamotrigine%20Tablets%20USP%2C%20100%20mg%20by%20Taro%20Pharmaceuticals&utm_medium=email&utm_source=Eloqua

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: Lamotrigine Tablets USP, 100 mg by Taro Pharmaceuticals: Recall - Due to cross-contamination with a small amount of another drug substance, enalapril maleate AUDIENCE: Patient, Health Professional, Pharmacy BACKGROUND: Lamotrigine tablets are indicated for epilepsy and bipolar disorder. Enalapril maleate is a drug substance indicated for hypertension and congestive heart failure. ISSUE: Taro Pharmaceuticals is recalling one (1) lot of Lamotrigine Tablets USP 100 mg, lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 because it was found to have been cross-contaminated with a small amount of another drug substance, enalapril maleate, used to manufacture another product at the same facility. Use of lamotrigine could potentially result in exposure to a small amount of enalapril maleate, if present in the product in question. There is potential, with chronic exposure to enalapril maleate, to impact users particularly if they are small children or pregnant women. Enalapril maleate is also associated with a risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine Tablets USP, 100 mg, lot # 331771. 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. RECOMMENDATION: Patients that have any quantities of Lamotrigine Tablets USP, 100 mg, lot # 331771 should stop using this product and return it to the pharmacy that dispensed it. Retailers, pharmacies and distributors should stop distributing or dispensing this product and return it to Taro.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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