FDA-Drug2015-03-11Class II

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.

Akorn, Inc.
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
44,448 bottles
Manufactured in
1925 W. Field Court, Suite 300, N/A, Lake Forest, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0405-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief