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Class II: temporary or reversible health riskTerminated

Akorn Fluticasone Propionate Nasal Spray Recall

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass b…

Akorn, Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jul 6, 2022
Recall ID
D-1172-2022
Check your lot numberHow we source this data

Summary

Akorn recalled Fluticasone Propionate Nasal Spray starting Jun 13, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1172-2022 on Jul 6, 2022. Reason: Defective container: defect prevents product from dispensing as intended. Status: Terminated.

Why it was recalled

Defective container: defect prevents product from dispensing as intended.

Product description

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16

Lot numbers, UPCs & expiration codes

Lot #: 379073, 379079, Exp 9/30/2023

Where it was sold

Nationwide USA

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-1172-2022
Classification
Class II
Status
Terminated
Recall initiated
Jun 13, 2022
FDA report date
Jul 6, 2022
Quantity
44,400 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-1172-2022, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
90405
Address
1925 W Field Ct Ste 300
Code information
Lot #: 379073, 379079, Exp 9/30/2023
Postal code
60045-4862
Report date
Jul 6, 2022
Product type
Drugs
Recall number
D-1172-2022
Classification
Class II
Recalling firm
Akorn, Inc.
Product quantity
44,400 bottles
Termination date
Jul 14, 2024
Reason for recall
Defective container: defect prevents product from dispensing as intended.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
Distribution pattern
Nationwide USA
Recall initiation date
Jun 13, 2022
Initial firm notification
Letter
Center classification date
Jun 30, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1172-2022, published Jul 6, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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