# FDA recall D-0823-2020

> **Macleods Pharma Usa Inc** · Class III · drug recall initiated 2020-01-20.

## Product

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India  NDC 33342-111-10

## Reason for recall

Failed Dissolution Specifications:  testing revealed low out of specification result in one lot of product

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0823-2020
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-20
- **Report date:** 2020-02-05
- **Termination date:** 2021-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0823-2020

## Citation

> AI Analytics. FDA recall D-0823-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0823-2020. Source: US FDA. Licensed CC0.

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