Recalls / Class II
Class IID-0405-2015
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.
- Affected lot / code info
- Lot #: 631639, Exp 01/2017.
Why it was recalled
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 44,448 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-02-27
- FDA classified
- 2015-03-05
- Posted by FDA
- 2015-03-11
- Terminated
- 2017-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0405-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.