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
Reported: September 29, 2021 Initiated: September 14, 2021 #D-0829-2021
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.
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 2 bottles
- Distribution
- FL only
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Direct Rx. Units affected: 2 bottles.
Why was this product recalled? ▼
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0829-2021.
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