Class II
Terminated
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
This recall has been terminated (originally issued October 26, 2016).
- Company
- Supernus Pharmaceuticals, Inc.
- Recall Initiated
- July 12, 2016
- Posted
- October 26, 2016
- Recall Number
- D-0112-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,128 (30-count blister packs)
- Firm Location
- Rockville, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug: Failure of assay specifications in the capsule.
Distribution
Nationwide
Lot / Code Info
Lot # 426636, Exp 4/22/18
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