# FDA recall D-0424-2019

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-02-01.

## Product

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.

## Reason for recall

Defective Container: Potential for broken glass in the neck area of the glass bottles.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0424-2019
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-01
- **Report date:** 2019-02-13
- **Termination date:** 2019-09-09

- **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-0424-2019

## Citation

> AI Analytics. FDA recall D-0424-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0424-2019. Source: US FDA. Licensed CC0.

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