# FDA recall D-0476-2023

> **Direct Rx** · Class II · drug recall initiated 2023-03-13.

## Product

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

## Reason for recall

cGMP deviations

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0476-2023
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-03-13
- **Report date:** 2023-04-05
- **Termination date:** 2024-06-17

- **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-0476-2023

## Citation

> AI Analytics. FDA recall D-0476-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0476-2023. Source: US FDA. Licensed CC0.

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