Supernus Pharmaceuticals, Inc.: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Supernus Pharmaceuticals, Inc.
- Product
- Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
- Reason / hazard
- Failed dissolution specifications.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-08-31
- Code info
- Lot# 2145283, Exp Date: 31-Mar-2030.
- Product quantity
- 11304 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Rockville
- State
- MD
- Country
- United States
- Event id
- 99767
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