D-0112-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 26, 2016
- Initiation Date
- July 12, 2016
- Termination Date
- February 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,128 (30-count blister packs)
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # 426636, Exp 4/22/18