Recalls / Class II
Class IID-0888-2022
Product
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
- Affected lot / code info
- Lot: 23JY2124 Exp. 6/30/23
Why it was recalled
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 16 bottles
- Distribution pattern
- Nationwide to the U.S. market
Timeline
- Recall initiated
- 2022-05-13
- FDA classified
- 2022-05-20
- Posted by FDA
- 2022-06-01
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0888-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.