Medications & Supplements/Prescription Drugs

Apotex Inc.: Fluticasone Propionate Nasal Spray Recalled for Glass Particles

Agency Publication Date: June 6, 2018

Summary

Apotex Inc. is recalling one lot of Fluticasone propionate Nasal Spray, USP, 50 mcg, which is a prescription medication used to treat seasonal and year-round allergy symptoms. The recall was initiated because of the presence of a foreign substance identified as glass particles found in the product. Consumers should immediately check their medicine cabinets for the affected bottles, which were distributed nationwide in 120-metered spray containers (16 g net fill weight).

Risk

The presence of glass particles in a nasal spray poses a serious risk of physical irritation or injury to the nasal mucosa, including potential cuts, swelling, or secondary infections. If the particles are inhaled further into the respiratory system, they could cause more significant internal damage or complications.

What You Should Do

Identify if you have the affected product by checking the bottle and outer carton for Fluticasone propionate Nasal Spray, USP, 50 mcg (NDC 60505-0829-1).
Look for Lot number NJ4501 with an expiration date of 07/2020 printed on the packaging.
Stop using the affected nasal spray immediately if your bottle matches the recalled lot number.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatment and to report any adverse health effects.
Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund.
Contact Apotex Corp. at 1-800-706-5575 or via email at USCustomerService@apotex.com for further instructions on how to return the product.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider and return product to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fluticasone propionate Nasal Spray, USP, 50 mcg (120 Metered Sprays, 16 g)

Model:

NDC 60505-0829-1

Recall #: D-0841-2018

Lot Numbers:

NJ4501 (Exp. 07/2020)

Date Ranges: Expiration 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80202

Status: Resolved

Manufacturer: Apotex Inc.

Manufactured In: Canada

Units Affected: Unknown

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

Risk

What You Should Do

Identify if you have the affected product by checking the bottle and outer carton for Fluticasone propionate Nasal Spray, USP, 50 mcg (NDC 60505-0829-1).

Look for Lot number NJ4501 with an expiration date of 07/2020 printed on the packaging.

Stop using the affected nasal spray immediately if your bottle matches the recalled lot number.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatment and to report any adverse health effects.

Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund.

Contact Apotex Corp. at 1-800-706-5575 or via email at USCustomerService@apotex.com for further instructions on how to return the product.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).