FDA recall D-0112-2017

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-07-12

Report date

2016-10-26

Termination date

2019-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockville, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2017