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.
D-0405-2015
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 70625
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,448 bottles
- Official record key
drug-enforcement:D-0405-2015
Official wording
Reason: Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Code information: Lot #: 631639, Exp 01/2017.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification