Class II
Terminated
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.
This recall has been terminated (originally issued March 11, 2015).
- Company
- Akorn, Inc.
- Recall Initiated
- February 27, 2015
- Posted
- March 11, 2015
- Recall Number
- D-0405-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44,448 bottles
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 631639, Exp 01/2017.
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