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Lamotrigine was contaminated with a heart drug.
Taro Pharmaceuticals is voluntarily recalling 1 lot of Lamotrigine (Lamictal) 100 mg. tablets, which treats bipolar disorder and seizures, after cross-contamination with a heart drug.
The Lamotrigine lot was cross-contaminated with a small amount of enalapril maleate (Vasotec, other brand names), used to manufacture another product at the same facility. Enalapril maleate treats hypertension and congestive heart failure.
“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 risk of birth defects in a developing fetus,” Taro said in a statement.
The recall applies to Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1.
The lot of Lamotrigine tablets was distributed to wholesale distributors in the U.S. market between August 23 and August 30, 2019. The distributors may have further distributed the lot to retail pharmacies.
“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,” the pharma maker said.
Retailers, pharmacies, and distributors should stop distributing or dispensing the product and return it to Taro.
Read more: FDA Announces 3 Big Drug Recalls