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Manufacturer Recalls Epilepsy Drug for Cross-Contamination with Blood Pressure Drug


February 12, 2020

UNITED STATES – Pharmaceutical manufacturer, Taro Pharmaceuticals, has recalled an epilepsy drug because it was cross-contaminated with a blood pressure drug. The affected medication was distributed during 2019, and patients are being asked to return any recalled product to the pharmacy and discontinue using the product immediately.*

The recalled drug is called lamotrigine, which is a medication prescribed for epilepsy and bipolar disorder. Taro indicates that one lot of the medication was cross-contaminated with a drug prescribed for hypertension and congestive heart failure, called enalapril maleate. Enalapril maleate is a type of ACE inhibitor. 

According to Taro, the recalled lot includes packages of 100 mg lamotrigine tablets with the NDC code 51672-4131-1. The lot number on the recalled product is 331771, and the expiration date is June 2021. Patients would have received this drug between August 23, 2019, and August 30, 2019. It does not appear that the same issue occurred with enalapril. No cross-contamination with this drug was reported in the news article. 

No adverse events related to the contaminated product have been reported at this time to Taro, according to the manufacturer. However, consumption of the recalled lamotrigine could have negative effects on patients, especially in pregnant women and children. Enalapril has been tied to development of birth defects, so pregnant women should take all precautions outlined in the recall. Adverse events related to ingestion of the recalled lamotrigine should be reported to the U.S. Food and Drug Administration. 

Taro is currently in the process of notifying consumers, retailers, and distributors of lamotrigine about the recall. Patients who have some of the recalled lot should stop taking the drug and should return it to their pharmacies. Patients or anyone with questions about the recall can direct those to Taro at (866) 923-4914 or at [email protected].

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Source:https://www.psychiatryadvisor.com/home/topics/mood-disorders/bipolar-disorder/lamotrigine-recalled-due-to-cross-contamination-with-hypertension-med/

Category: Product Liability

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