Why it was recalled
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
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.
Lot numbers, UPCs & expiration codes
Lot #: 631639, Exp 01/2017.
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0405-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 27, 2015
- FDA report date
- Mar 11, 2015
- Quantity
- 44,448 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0405-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70625
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot #: 631639, Exp 01/2017.
- Postal code
- 60045
- Report date
- Mar 11, 2015
- Product type
- Drugs
- Recall number
- D-0405-2015
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 44,448 bottles
- Termination date
- Nov 30, 2017
- Reason for recall
- Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 27, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2015