Trokendi Xr Capsule, Extended Release
FDA Recall NDC 17772-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Trokendi Xr (NDC 17772-101). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Supernus Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
490 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30
Batch or Lot Expiration Information
Lot# 1741214
Affected Packages Involved in this Recall
17772-102-70Product
17772-102-01Product
17772-102-30Product
17772-102-15Product
17772-102-10Product
17772-102-12Product
17772-102-07Product
17772-103-70Product
17772-103-01Product
17772-103-30Product
17772-103-15Product
17772-103-10Product
17772-103-12Product
17772-103-07Product
17772-104-70Product
17772-104-01Product
17772-104-30Product
17772-104-15Product
17772-104-12Product
17772-104-10Product
17772-104-07Product
17772-101-70Product
17772-101-01Product
17772-101-30Product
17772-101-15Product
17772-101-10Product
17772-101-12Product
17772-101-07Product
Class II Terminated
Superpotent Drug: Failure of assay specifications in the capsule.
Jul 12, 2016
Oct 26, 2016
17,128 (30-count blister packs)
Recall Profile & Regulatory Data
Event ID
74988
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Supernus Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2019
Product Description
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
Affected Packages Involved in this Recall
17772-102-70Product
17772-102-01Product
17772-102-30Product
17772-102-15Product
17772-102-10Product
17772-102-12Product
17772-102-07Product
17772-103-70Product
17772-103-01Product
17772-103-30Product
17772-103-15Product
17772-103-10Product
17772-103-12Product
17772-103-07Product
17772-104-70Product
17772-104-01Product
17772-104-30Product
17772-104-15Product
17772-104-12Product
17772-104-10Product
17772-104-07Product
17772-101-70Product
17772-101-01Product
17772-101-30Product
17772-101-15Product
17772-101-10Product
17772-101-12Product
17772-101-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
