Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30
Recall Number: D-0570-2021
Firm: Cardinal Health Inc.
Classification: Class II
Status: Terminated
Report Date: 20210602
Initiation Date: 20210315
Termination Date: 20240617
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product Description
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30