FDA-Drug2021-06-02Class II
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
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
490 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2021Don't want to check this manually?
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