Recalls / Class II
Class IID-0793-2022
Product
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, 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
- a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023
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
- a) 7,044 bottles; b) 1,014 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2022-04-25
- FDA classified
- 2022-04-27
- Posted by FDA
- 2022-05-04
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0793-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.