Recalls / Class II
Class IID-0825-2021
Product
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Brand name
- Zonisamide
- Generic name
- Zonisamide
- Active ingredient
- Zonisamide
- Route
- Oral
- NDCs
- 68462-128, 68462-129, 68462-130
- FDA application
- ANDA077651
- Affected lot / code info
- Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 15936 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2021-08-27
- FDA classified
- 2021-09-21
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0825-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.