# FDA recall D-0888-2022

> **Direct Rx** · Class II · drug recall initiated 2022-05-13.

## Product

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.

## Distribution

Nationwide to the U.S. market

## Key facts

- **Recall number:** D-0888-2022
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-13
- **Report date:** 2022-06-01
- **Termination date:** 2024-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0888-2022

## Citation

> AI Analytics. FDA recall D-0888-2022. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0888-2022. Source: US FDA. Licensed CC0.

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