Zonisamide Capsules USP recall: CGMP Deviations
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Why was Zonisamide Capsules USP recalled?
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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: 23JY2124 Exp. 6/30/23
- Product
- Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
- Recalling firm
- Direct Rx
- Quantity
- 16 bottles
- Distribution
- Nationwide to the U.S. market
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)