FDAClass IIOctober 26, 2016

Trokendi XR recall: Superpotent

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY…

Why was Trokendi XR recalled?

Superpotent Drug: Failure of assay specifications in the capsule.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 426636, Exp 4/22/18

Product
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY…
Recalling firm
Supernus Pharmaceuticals, Inc.
Quantity
17,128 (30-count blister packs)
Distribution
Nationwide
Recall date
October 26, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls