Drug 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
D-0112-2017
Product summary
- Event
- Event 74988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,128 (30-count blister packs)
- Official record key
drug-enforcement:D-0112-2017
Official wording
Reason: Superpotent Drug: Failure of assay specifications in the capsule.
Code information: Lot # 426636, Exp 4/22/18
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent