FDA-Drug2016-10-26Class II
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
Supernus Pharmaceuticals, Inc.
Hazard
Superpotent Drug: Failure of assay specifications in the capsule.
Sold states
Nationwide
Affected count
17,128 (30-count blister packs)
Manufactured in
1550 E Gude Dr, N/A, Rockville, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2017Don't want to check this manually?
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