October 26, 2016
A nationwide recall of topiramate extended-release capsule (Trokendi XR; Supernus) is still ongoing, according to this week’s FDA report.
The Class II recall included 17,128, 30-count blister packs or 50 mg capsules. The reason for recall was stated as “superpotent drug: failure of assay specifications in the capsule.” The affected lot is number 426636, expiration date April 22, 2018.
Trokendi XR capsules, a sulfamate-substituted monosaccharide, is indicated to treat partial-onset seizures and primary generalized tonic-clonic seizures in people aged 10 years of age and older. It is also used as initial monotherapy in patients aged 10 years and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients aged 6 years and older.
Supernus Pharmaceuticals, Inc voluntarily initiated the recall beginning July 12, 2016; center classification date was on October 20, 2016. —Amanda Del Signore