# FDA recall D-1075-2018

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2018-07-25.

## Product

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only,  Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23

## Reason for recall

Presence of foreign substance: Potential for glass in the neck area of the glass bottles.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1075-2018
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-25
- **Report date:** 2018-08-15
- **Termination date:** 2019-08-15

- **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-1075-2018

## Citation

> AI Analytics. FDA recall D-1075-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1075-2018. Source: US FDA. Licensed CC0.

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