# FDA recall D-0920-2017

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2017-05-09.

## Product

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

## Reason for recall

Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0920-2017
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-09
- **Report date:** 2017-06-21
- **Termination date:** 2018-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0920-2017

## Citation

> AI Analytics. FDA recall D-0920-2017. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0920-2017. Source: US FDA. Licensed CC0.

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