# FDA recall D-0417-2018

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2018-02-05.

## Product

Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91

## Reason for recall

Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0417-2018
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-05
- **Report date:** 2018-02-21
- **Termination date:** 2019-03-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0417-2018

## Citation

> AI Analytics. FDA recall D-0417-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0417-2018. Source: US FDA. Licensed CC0.

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