Taro Pharmaceuticals, a Hawthorne, N.Y.-based drugmaker, is recalling one lot of its drug, Lamotrigine, designed to treat epilepsy and bipolar disorder, after discovering it was cross-contaminated with a small amount of another drug substance.
The drugmaker said Jan. 10 it discovered the lot contained a small amount of Enalapril Maleate, a drug substance used to manufacture another drug at the same facility. Enalapril Maleate is used to treat congestive heart failure and hypertension.
Chronic exposure to Enalapril Maleate increases the risk of birth defects in a developing fetus.
Taro has not received any reports of adverse events related to the recall.
Consumers with the affected lot should return the Lamotrigine tablets to their pharmacy. Retailers, pharmacies and distributors should stop distributing or dispensing the affected product and return it to Taro.
Read the full news release here.