Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured
Summary
The FDA issued a Class II for Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals by Glenmark Pharmaceuticals Inc., USA. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0826-2021
Action Date
2021-09-29
Status
Terminated
Category
drug
Product Description
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Lot/Code Info: Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023
Quantity Affected: a) 216,454 bottles; b) 2166 bottles
Reason for Recall
CGMP Deviations
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-27
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 42 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-0826-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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