Medications & Supplements/Prescription Drugs

Fluticasone Propionate Nasal Spray Recalled for Potential Contamination

Agency Publication Date: September 30, 2024

Summary

Golden State Medical Supply Inc. is recalling 59,712 bottles of Fluticasone Propionate Nasal Spray USP (50 mcg per spray) due to manufacturing deviations and the suspected presence of Burkholderia cepacia complex bacteria. The recall affects 16 g bottles containing 120 metered sprays that were distributed nationwide. Consumers should consult their doctor if they have used this product and are concerned about their health.

Risk

Burkholderia cepacia complex is a group of bacteria that can cause serious infections, especially in people with weakened immune systems or chronic lung diseases. These infections can be life-threatening and are often resistant to common antibiotics.

What You Should Do

The recalled product is Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, sold in 16 g bottles (120 metered sprays) with NDC 60429-195-15.
Check the bottle and packaging for lot number TX5275 and an expiration date of 10/31/2026 to determine if your medication is included in this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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 per spray, 120 metered sprays, Rx only

Lot Numbers:

TX5275 (Exp. 10/31/2026)

NDC:

60429-195-15

Manufactured by Apotek Inc., Toronto, Canada; Marketed by GSMS Incorporated, Camarillo, CA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94029

Status: Active

Manufacturer: Golden State Medical Supply Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: Canada

Units Affected: 59,712 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

The recalled product is Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, sold in 16 g bottles (120 metered sprays) with NDC 60429-195-15.

Check the bottle and packaging for lot number TX5275 and an expiration date of 10/31/2026 to determine if your medication is included in this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.

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