Taro Pharmaceuticals U.S.A. is recalling one lot of Lamotrigine tablets.
The product was cross-contaminated with Enalapril Maleate which is used to treat hypertension and congestive heart failure.
Enalapril Maleate, which is used to treat Epilepsy and Bipolar disorder, can affect users -- particularly small children or pregnant women. It is also associated with risk of birth defects in a developing fetus.
No product complaints or adverse events have been reported to date.
The following product, packaged in white plastic bottles with screw cap closure containing 100 tablets, is being recalled:
- Lamotrigine Tablets USP, 100 mg, NDC #51672-4131-1, lot number 331771 and expiration date of June 2021.
The recalled product was shipped to wholesale customers in the US market from August 23 – 30, 2019. who may may have further distributed them to retail pharmacies for prescription dispensing to patients
What to do
Patients who have the recalled product should stop using and return it to the pharmacy that dispensed it.
Consumers with questions may contact Taro at (866) 923-4914 Monday through Friday from 7:00 AM – 7:00 PM (CT), or by e-mail at TaroPVUS@taro.com.