PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: March 11, 2015 Initiated: February 27, 2015 #D-0405-2015

Product Description

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.

Details

Recalling Firm
Akorn, Inc.
Units Affected
44,448 bottles
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product 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.. Recalled by Akorn, Inc.. Units affected: 44,448 bottles.
Why was this product recalled?
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 11, 2015. Severity: Moderate. Recall number: D-0405-2015.