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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Apotex Fluticasone Propionate Nasal Spray Recalled for Potential Bacteria

Agency Publication Date: February 16, 2024
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Summary

Apotex Corp. is recalling approximately 292,752 bottles of Fluticasone Propionate Nasal Spray USP 50mcg. This prescription allergy medication is being recalled due to manufacturing deviations that may have led to the presence of Burkholderia cepacia complex bacteria. The recall involves 16g bottles containing 120 metered sprays identified by NDC 60505-0829-1.

Risk

Burkholderia cepacia complex is a group of bacteria that can cause serious, potentially life-threatening infections in individuals with weakened immune systems or chronic lung conditions like cystic fibrosis. No injuries or illnesses have been reported to date regarding this recall.

What You Should Do

  1. The recalled product is Fluticasone Propionate Nasal Spray USP 50mcg (120 metered sprays, 16g fill) labeled with NDC 60505-0829-1, lot number TX5274, and expiration date 09/30/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Apotex Corp. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 50mcg (16 g)
Variants: 120 Metered Sprays, Rx Only
Lot Numbers:
TX5274 (Exp. 09/30/2026)
NDC:
60505-0829-1

Recall #: D-0326-2024; Manufactured by Apotex Inc. in Toronto, Canada; Manufactured for Apotex Corp. in Weston, FL.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93974
Status: Active
Manufacturer: Apotex Corp.
Manufactured In: Canada, United States
Units Affected: 292,752 bottles
Distributed To: Nationwide
Agency Last Updated: March 27, 2024

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 ยท 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.