Zonisamide Capsules USP recall: CGMP Deviations
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
Why was Zonisamide Capsules USP recalled?
cGMP deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 29200052, Exp 4/30/2023
- Product
- 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
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 11,136 bottles
- Distribution
- USA nationwide
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)