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…

Recall date

February 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0405-2015

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.