Recalls / Class II
Class IID-0112-2017
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
- Brand name
- Trokendi Xr
- Generic name
- Topiramate
- Active ingredient
- Topiramate
- Route
- Oral
- NDCs
- 17772-101, 17772-102, 17772-103, 17772-104
- FDA application
- NDA201635
- Affected lot / code info
- Lot # 426636, Exp 4/22/18
Why it was recalled
Superpotent Drug: Failure of assay specifications in the capsule.
Recalling firm
- Firm
- Supernus Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1550 E Gude Dr, N/A, Rockville, Maryland 20850-1339
Distribution
- Quantity
- 17,128 (30-count blister packs)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-07-12
- FDA classified
- 2016-10-20
- Posted by FDA
- 2016-10-26
- Terminated
- 2019-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0112-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.