Drug Safety Alerts

Lamotrigine 200 mg Orally Disintegrating Tablets Class I Recall

12/28/2016

On December 28, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of lamotrigine 200 mg orally disintegrating tablets (ODT) manufactured by Impax Laboratories.This recall was issued because the childproof shell packs labeled as 200 mg ODT may potentially contain 100 mg ODT. As a result, it is possible that patients could take a lower than their intended lamotrigine dose. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.

This recall affects lot number 502240 exp. 11/30/17. The affected lot went into distribution on June 13, 2016.

This recall was originally issued on August 22, 2016 to the retail-level. The FDA classified this as a Class I recall on December 28, 2016.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking lamotrigine 200 mg ODTto contact their prescriber.

For more information, health care providers may contact Impax Laboratories at 1-877-994-6729. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their web site at https://www.accessdata.fda.gov.