July 2016 FDA Recall Trokendi Xr by Supernus Pharmaceuticals, Inc.
D-0112-2017 - Superpotent Drug
This Class II drug recall was voluntarily initiated by Supernus Pharmaceuticals, Inc. on July 12, 2016 for the product Trokendi Xr. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0112-2017
Superpotent Drug: Failure of assay specifications in the capsule.
07-12-2016
10-26-2016
17,128 (30-count blister packs)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Supernus Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-26-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 426636, Exp 4/22/18
