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Class II: temporary or reversible health riskTerminated

Supernus Pharmaceuticals Trokendi XR Recall

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only…

Supernus Pharmaceuticals, Inc. · Rockville, MD

Risk level
Class II
Reported by FDA
Oct 26, 2016
Recall ID
D-0112-2017
Check your lot numberHow we source this data

Summary

Supernus Pharmaceuticals recalled Trokendi XR starting Jul 12, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0112-2017 on Oct 26, 2016. Reason: Superpotent Drug: Failure of assay specifications in the capsule. Status: Terminated.

Why it was recalled

Superpotent Drug: Failure of assay specifications in the capsule.

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

Lot numbers, UPCs & expiration codes

Lot # 426636, Exp 4/22/18

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0112-2017
Classification
Class II
Status
Terminated
Recall initiated
Jul 12, 2016
FDA report date
Oct 26, 2016
Quantity
17,128 (30-count blister packs)
Recall type
Voluntary: Firm initiated
Recalling firm
Supernus Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0112-2017, exactly as published.

Show all FDA fields
City
Rockville
State
MD
Status
Terminated
Country
United States
Event ID
74988
Address
1550 E Gude Dr
Code information
Lot # 426636, Exp 4/22/18
Postal code
20850-1339
Report date
Oct 26, 2016
Product type
Drugs
Recall number
D-0112-2017
Classification
Class II
Recalling firm
Supernus Pharmaceuticals, Inc.
Product quantity
17,128 (30-count blister packs)
Termination date
Feb 26, 2019
Reason for recall
Superpotent Drug: Failure of assay specifications in the capsule.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Jul 12, 2016
Initial firm notification
E-Mail
Center classification date
Oct 20, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0112-2017, published Oct 26, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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