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
Reported: June 1, 2022 Initiated: May 13, 2022 #D-0888-2022
Product Description
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
Reason for Recall
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 16 bottles
- Distribution
- Nationwide to the U.S. market
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Direct Rx. Units affected: 16 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 June 1, 2022. Severity: Moderate. Recall number: D-0888-2022.
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