FDA recall D-0825-2021
Glenmark Pharmaceuticals Inc., USA · Class II · drug
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
Reason for recall
CGMP Deviations
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-27
- Report date
- 2021-09-29
- Termination date
- 2023-10-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mahwah, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0825-2021