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Taro Pharmaceuticals U.S.A., Inc. Recalls Lamotrigine Tablets

Date: 01/16/20

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On January 10, 2020, the U.S. Food and Drug Administration (FDA) announced that Taro Pharmaceuticals U.S.A., Inc. was recalling one lot of Lamotrigine Tablets to the consumer level due to cross-contamination with Enalapril Maleate.

The FDA press release states the following:

Taro Pharmaceuticals U.S.A., Inc. is voluntary recalling one lot of Lamotrigine 100 mg tablets to the consumer level due to cross-contamination with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility. Lamotrigine 100 mg tablets are indicated for Epilepsy and Bipolar disorder. Use of the recalled Lamotrigine 100 mg tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for 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. Therefore, there is risk associated with the continued, long-term use of the recalled Lamotrigine 100 mg tablets.

Please immediately check your medical supplies, quarantine any drug products impacted, and do not administer them. The NDC and lot number associated with Taro’s recalled product is as follows: Lamotrigine 100 mg tablets (NDC 51672-4131-01; Lot 331771; expiration date June 2021).

Providers can review the FDA’s full press release here.