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
Reported: May 4, 2022 Initiated: April 25, 2022 #D-0791-2022
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
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 11,136 bottles
- Distribution
- USA nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 11,136 bottles.
Why was this product recalled? ▼
cGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0791-2022.
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