FDA Drug recall D-0405-2015
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations,…
- FDA Drug
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations,… by Akorn, citing failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0405-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-27 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Identifiers
| code_info | Lot #: 631639, Exp 01/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0405-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.