Medications & Supplements/Prescription Drugs

Akorn Fluticasone Propionate Nasal Spray Recalled for Defective Container

Agency Publication Date: June 30, 2022

Summary

Akorn, Inc. is recalling 44,400 bottles of Fluticasone Propionate Nasal Spray (50 mcg, 16 g net fill weight) because the amber glass bottles may have a defect that prevents the medicine from spraying correctly. This recall affects the generic version of the steroid nasal spray commonly used to treat allergy symptoms. While no injuries or medical incidents have been reported, the defect prevents users from receiving their intended dosage.

Risk

The defective container prevents the medication from dispensing as intended. If the spray mechanism fails, patients will not receive their prescribed dose of medication, potentially leading to untreated or worsening allergy and inflammation symptoms.

What You Should Do

This recall affects 44,400 bottles of Fluticasone Propionate Nasal Spray, USP, 50 mcg (16 g net fill weight) manufactured by Hi-Tech Pharmacal Co., Inc. under NDC 50383-700-16.
Check the label on your nasal spray bottle for lot numbers 379073 or 379079 with an expiration date of 9/30/2023 to determine if your product is included in this recall.
If you have health concerns regarding your medication or have experienced issues with the spray bottle, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Akorn, Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fluticasone Propionate Nasal Spray, USP (16 g)

Variants: 50 mcg, Amber glass bottle

Lot Numbers:

379073 (Exp 9/30/2023)

379079 (Exp 9/30/2023)

NDC:

50383-700-16

Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90405

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 44,400 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 44,400 bottles of Fluticasone Propionate Nasal Spray, USP, 50 mcg (16 g net fill weight) manufactured by Hi-Tech Pharmacal Co., Inc. under NDC 50383-700-16.

Check the label on your nasal spray bottle for lot numbers 379073 or 379079 with an expiration date of 9/30/2023 to determine if your product is included in this recall.

If you have health concerns regarding your medication or have experienced issues with the spray bottle, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Akorn, Inc. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.