Recalls / Class II
Class IID-0829-2021
Product
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
- Affected lot / code info
- Lot #: 17JU2118 Exp. 5/31/23
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
- 2 bottles
- Distribution pattern
- FL only
Timeline
- Recall initiated
- 2021-09-14
- FDA classified
- 2021-09-23
- Posted by FDA
- 2021-09-29
- Terminated
- 2021-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0829-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.