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
Reported: October 26, 2016 Initiated: July 12, 2016 #D-0112-2017
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.
Details
- Recalling Firm
- Supernus Pharmaceuticals, Inc.
- Units Affected
- 17,128 (30-count blister packs)
- Distribution
- Nationwide
- Location
- Rockville, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Supernus Pharmaceuticals, Inc.. Units affected: 17,128 (30-count blister packs).
Why was this product recalled? ▼
Superpotent Drug: Failure of assay specifications in the capsule.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 26, 2016. Severity: Moderate. Recall number: D-0112-2017.
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