Zonisamide 100 mg Capsules recall: CGMP Deviations
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
Why was Zonisamide 100 mg Capsules 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 #: 17JU2118 Exp. 5/31/23
- Product
- Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
- Recalling firm
- Direct Rx
- Quantity
- 2 bottles
- Distribution
- FL only
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)