Drug & medication recalls Moderate risk

Supernus Pharmaceuticals, Inc. recalls Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Phar…

Recall date
July 12, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0112-2017
FDA classification
Class II
Brand / firm
Supernus Pharmaceuticals, Inc.
Sold / distributed
Nationwide

Why it was recalled

Superpotent Drug: Failure of assay specifications in the capsule.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15

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