Class II
Terminated
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
- Company
- Direct Rx
- Recall Initiated
- September 14, 2021
- Posted
- September 29, 2021
- Recall Number
- D-0829-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2 bottles
- Firm Location
- Dawsonville, GA, United States
Reason for Recall
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Distribution
FL only
Lot / Code Info
Lot #: 17JU2118 Exp. 5/31/23
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