Fluticasone Propionate Nasal Spray — Class II drug recall D-0405-2015
Terminated recall by Akorn, Inc., reported 2015-03-11, distributed nationwide. Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
| Recall number | D-0405-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-02-27 |
| Classified | 2015-03-05 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 44,448 bottles |
| Reason classes | specification failure |
| NDC | 50383-0700-16 |
| Lot numbers | 631639 |
| Expiration dates | 2017-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0405-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.