D-0829-2021 Class II Terminated
FDA drug recall D-0829-2021 was initiated by Direct Rx on September 14, 2021 and is designated Class II. Reason for recall: CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. The recall status is terminated (terminated October 22, 2021). Affected quantity: 2 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- September 14, 2021
- Termination Date
- October 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bottles
Product Description
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
Reason for Recall
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Distribution Pattern
FL only
Code Information
Lot #: 17JU2118 Exp. 5/31/23