FDAFDA · Food and drugs·Recall number D-0405-2015
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.
Published March 11, 2015 · Recall initiated: February 27, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 631639, Exp 01/2017.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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