FDA recall D-0405-2015

Akorn, Inc. · Class II · drug

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 for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-02-27
Report date: 2015-03-11
Termination date: 2017-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

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