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Medication Safety Alerts

Lamotrigine 200 mg Orally Disintegrating Tablets Voluntary Recall

12/28/2016

On December 28, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary 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 members could take a lower than their intended lamotrigine dose.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 502240 exp. 11/30/17. To see if you received product from these affected lots, please check the lot number. The lot number can be found on the side of the manufacturer’s carton as well as on the blister cards within the unit-of-use blister packs. If your product is not from lot number 502240, it is not affected by this recall. If your product is from lot number 502240, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking lamotrigine 200 mg ODT, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking lamotrigine 200 mg ODT and have questions regarding this recall, please call your doctor or call Impax Laboratories toll-free at 1-877-994-6729. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888‑463‑6332) or visit their Web site at https://www.accessdata.fda.gov/.

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