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Class II: temporary or reversible health riskCompleted

Glenmark Pharmaceuticals Zonisamide Capsules Recall

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01)

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Risk level
Class II
Reported by FDA
May 4, 2022
Recall ID
D-0793-2022
Check your lot numberHow we source this data

Summary

Glenmark Pharmaceuticals recalled Zonisamide Capsules starting Apr 25, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0793-2022 on May 4, 2022. Reason: cGMP deviations. Status: Completed.

Why it was recalled

cGMP deviations

Product description

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Lot numbers, UPCs & expiration codes

a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023

Where it was sold

USA 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-0793-2022
Classification
Class II
Status
Completed
Recall initiated
Apr 25, 2022
FDA report date
May 4, 2022
Quantity
a) 7,044 bottles; b) 1,014 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glenmark Pharmaceuticals Inc., USA

Original FDA data

Every field from FDA enforcement report D-0793-2022, exactly as published.

Show all FDA fields
City
Mahwah
State
NJ
Status
Completed
Country
United States
Event ID
90029
Address
750 Corporate Dr
Code information
a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023
Postal code
07430-2009
Report date
May 4, 2022
Product type
Drugs
Recall number
D-0793-2022
Classification
Class II
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product quantity
a) 7,044 bottles; b) 1,014 bottles
Reason for recall
cGMP deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Distribution pattern
USA nationwide
Recall initiation date
Apr 25, 2022
Initial firm notification
Letter
Center classification date
Apr 27, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0793-2022, published May 4, 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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