Taro Pharma Recalls Certain Lot Of Lamotrigine Tablets

(RTTNews) - Taro Pharmaceuticals U.S.A., Inc., the U.S.-based business of Israeli Pharma firm Taro Pharmaceutical Industries, Ltd., recalled a certain lot of epilepsy and bipolar disorder medication Lamotrigine in the form of tablets for the potential cross-contamination, the U.S. Food and Drug Administration revealed.

The tablets were found to have been cross-contaminated with a small amount of another drug substance, Enalapril Maleate, used to make another product at the same facility. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure.

The company is recalling one lot of Lamotrigine tablets of 100 mg strength that are packaged in and 100 count white plastic bottles with expiration date of June 2021. The tablets were distributed across the U.S. to wholesalers between August 23 and August 30, 2019.

Taro Pharma is yet to receive any reports of adverse effects following contamination with Enalapril Maleate.

The company warned that any such contamination would affect users, particularly small children or pregnant women, for continued, long-term use. It is also associated with risk of birth defects in a developing fetus.

Lamotrigine is an anti-epileptic medication, also called an anticonvulsant. It is used alone or with other medications to treat epileptic seizures in adults and children. It is also used to delay mood episodes in adults with bipolar disorder (manic depression). Lamotrigine was first marketed in the U.K. in 1991 and approved for use in the U.S. in 1994.

The company urged consumers to stop using the products and also return them to the seller.