Taro Pharmaceuticals announced the voluntary recall of 1 lot of lamotrigine 100mg tablets to the consumer level due to cross-contamination with a small amount of enalapril maleate.
The recalled lot, Lamotrigine Tablets 100mg; NDC 51672-4131-1 (100 tabs); Lot Number 331771; Exp date 6/2021, was distributed between August 23 and August 30, 2019. Lamotrigine is indicated for the treatment of epilepsy and bipolar disorder. Enalapril maleate, an ACE inhibitor, is indicated for the treatment of hypertension and congestive heart failure.
According to Taro, long-term use of the recalled product could potentially impact users, particularly small children or pregnant women. Moreover, enalapril use has been associated with the risk of birth defects in a developing fetus. At this time, Taro has not received any reports of adverse events or product complaints.
The Company has notified its distributors, retailers, and consumers regarding the return of the recalled product. Patients in possession of the affected lot of lamotrigine should discontinue use and immediately return the product to the pharmacy. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.
Consumers with questions regarding the recall can contact Taro at (866) 923-4914 or via email at TaroPVUS@taro.com.
For more information visit taro.com.