Drugplain

Zonisamide 25 mg/1

Zonisamide · CAPSULE · Unichem Pharmaceuticals (USA), Inc.

10 Recalls on Record
Plain English

Zonisamide is a capsule containing zonisamide at 25 mg/1, taken oral. Manufactured by Unichem Pharmaceuticals (USA), Inc..

Key Facts

Brand Name
Zonisamide
Generic Name
Zonisamide
NDC Code (Product)
29300-428
Manufacturer
Unichem Pharmaceuticals (USA), Inc.
Strength
25 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA214492
Drug Class
Anti-epileptic Agent [EPC]
Marketing Start
07/09/2021

Recall History

10 Recalls on Record
Class II06/01/2015

American Health Packaging

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II08/27/2021

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/25/2022

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

CompletedVoluntary: Firm initiated
Class II05/13/2022

Direct Rx

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

TerminatedVoluntary: Firm initiated
Class II04/25/2022

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

CompletedVoluntary: Firm initiated
Class II08/27/2021

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II09/14/2021

Direct Rx

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

TerminatedVoluntary: Firm initiated
Class II04/25/2022

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

CompletedVoluntary: Firm initiated

Frequently Asked Questions

What is Zonisamide used for?

Zonisamide contains Zonisamide. It is a capsule taken oral. Consult your doctor for specific uses.

Is Zonisamide a controlled substance?

Zonisamide is not classified as a controlled substance by the DEA.

What is the generic name for Zonisamide?

The generic name for Zonisamide is Zonisamide. There are 2 other brand versions of Zonisamide.

What is the NDC code for Zonisamide 25 mg/1?

The NDC (National Drug Code) for Zonisamide 25 mg/1 is 29300-428, listed by Unichem Pharmaceuticals (USA), Inc..