# FDA recall D-0448-2017

> **Roxane Laboratories, Inc.** · Class III · drug recall initiated 2016-12-14.

## Product

Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99

## Reason for recall

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-0448-2017
- **Recalling firm:** Roxane Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-14
- **Report date:** 2017-02-01
- **Termination date:** 2017-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2017

## Citation

> AI Analytics. FDA recall D-0448-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0448-2017. Source: US FDA. Licensed CC0.

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