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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