D-0405-2015 Class II Terminated
FDA drug recall D-0405-2015 was initiated by Akorn, Inc. on Feb 27, 2015 and is designated Class II. Reason for recall: Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. The recall status is terminated (terminated Nov 30, 2017). Affected quantity: 44,448 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 11, 2015
- Initiation Date
- Feb 27, 2015
- Termination Date
- Nov 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,448 bottles
Product Description
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 631639, Exp 01/2017.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0405-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026