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
FDA recall notice · announced October 26, 2016 · Supernus Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Reason for recall
Superpotent Drug: Failure of assay specifications in the capsule.
Notes
Distribution: Nationwide
Lot/code information: Lot # 426636, Exp 4/22/18
Quantity: 17,128 (30-count blister packs)
Status: Terminated
Products in this recall event:
- 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, I (D-0112-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.