# FDA recall D-0405-2015

> **Akorn, Inc.** · Class II · drug recall initiated 2015-02-27.

## Product

Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray,  in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.

## Reason for recall

Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0405-2015
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-27
- **Report date:** 2015-03-11
- **Termination date:** 2017-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0405-2015

## Citation

> AI Analytics. FDA recall D-0405-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0405-2015. Source: US FDA. Licensed CC0.

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