Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc.,
Summary
The FDA issued a Class II for Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufact by Glenmark Pharmaceuticals Inc., USA. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0791-2022
Action Date
2022-05-04
Status
Completed
Category
drug
Product Description
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Lot/Code Info: Lot #: 29200052, Exp 4/30/2023
Quantity Affected: 11,136 bottles
Reason for Recall
cGMP deviations
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-25
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 121 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0791-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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