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Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that prov

Recalled March 11, 2015 · FDA recall D-0405-2015 · Akorn

Hazard
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. · FDA Class II
Units
44,448 bottles
Sold at
Nationwide and Puerto Rico

Description

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

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.
Manufacturer(s)
Akorn, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that prov | RecallWatchUSA