# FDA recall D-0829-2021

> **Direct Rx** · Class II · drug recall initiated 2021-09-14.

## Product

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

FL only

## Key facts

- **Recall number:** D-0829-2021
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-14
- **Report date:** 2021-09-29
- **Termination date:** 2021-10-22

- **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-0829-2021

## Citation

> AI Analytics. FDA recall D-0829-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0829-2021. Source: US FDA. Licensed CC0.

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