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Medication Safety Alerts

Trokendi® XR 200 mg Capsules Voluntary Recall

12/8/2016

On December 8, 2016, Supernus Pharma
issued a voluntary recall of Trokendi® XR 200 mg capsules. This recall was issued because the packaging may not meet the child-resistance standards as required by the Poison Prevention Packaging Act (PPPA). There is nothing wrong with the medication itself. The product meets all quality requirements specified by the United States Food and Drug Administration (FDA). Because the manufacturer’s child-resistance packaging may not meet PPPA standards, there is an increased chance that young children could access the medication, which could harm the children.

You should not stop taking your medication without first talking with your doctor. There is nothing wrong with the medication itself.  

This recall affects lot number 476916 exp. 06/11/19. To see if you received affected product, please check the lot number. The lot number is located on the lower left hand side of the manufacturer’s label. If your product is not from lot number 476916, it is not affected by this recall. If your product is from lot number 476916, please keep the medication out of the reach of children and contact the pharmacy that filled your prescription for further instructions.

CVS Caremark Response: If you are currently taking Trokendi XR 200 mg capsules from the affected lot, 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 Trokendi XR 200 mg capsules and have questions regarding this recall, please call your doctor or call Supernus Pharma Customer Service toll-free at 1-866-398-0833 or visit www.supernus.com . You may also call the FDA consumer inquiry line toll-free at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/cder .

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