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Class II: temporary or reversible health riskTerminated

Direct Rx Zonisamide Capsules Recall

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By…

Direct Rx · Dawsonville, GA

Risk level
Class II
Reported by FDA
Jun 1, 2022
Recall ID
D-0888-2022
Check your lot numberHow we source this data

Summary

Direct Rx recalled Zonisamide Capsules starting May 13, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0888-2022 on Jun 1, 2022. Reason: CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Status: Terminated.

Why it was recalled

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Product description

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

Lot numbers, UPCs & expiration codes

Lot: 23JY2124 Exp. 6/30/23

Where it was sold

Nationwide to the U.S. market

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-0888-2022
Classification
Class II
Status
Terminated
Recall initiated
May 13, 2022
FDA report date
Jun 1, 2022
Quantity
16 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Direct Rx

Original FDA data

Every field from FDA enforcement report D-0888-2022, exactly as published.

Show all FDA fields
City
Dawsonville
State
GA
Status
Terminated
Country
United States
Event ID
90215
Address
94 Worldwide Dr
Code information
Lot: 23JY2124 Exp. 6/30/23
Postal code
30534-6828
Report date
Jun 1, 2022
Product type
Drugs
Recall number
D-0888-2022
Classification
Class II
Recalling firm
Direct Rx
Product quantity
16 bottles
Termination date
Sep 30, 2024
Reason for recall
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Distribution pattern
Nationwide to the U.S. market
Recall initiation date
May 13, 2022
Initial firm notification
Letter
Center classification date
May 20, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0888-2022, published Jun 1, 2022. 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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