Apotex recalls Fluticasone Propionate Nasal Spray 50mcg 120 sprays due to potential Burkholderia cepacia contamination. This may pose health risks for users with compromised immune systems.
CGMP Deviations: potential presence of Burkholderia cepacia complex
Apotex is recalling Fluticasone Propionate Nasal Spray 50mcg (120 sprays) because it may contain Burkholderia cepacia complex, a bacteria that can cause infections in people with weakened immune systems. This recall affects prescription nasal sprays sold in the U.S. with specific lot numbers and expiration dates.
Burkholderia cepacia complex is a type of bacteria that can cause serious infections in people with compromised immune systems. This contamination may occur during manufacturing and could lead to health issues if the spray is used without proper precautions.
Prescription users of this nasal spray, particularly those with weakened immune systems, are most at risk due to potential bacterial contamination.
Check for the product name 'Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays' with lot number #TX5274 and expiration date 09/30/2026. The product is manufactured by Apotex Inc. in Toronto, Ontario, Canada.
Verify the lot number and expiration date on the product label to confirm if it matches #TX5274 expiring 09/30/2026.
The recall indicates potential contamination with Burkholderia cepacia complex, which may pose health risks for people with weakened immune systems. The product is not recommended for use until the recall is addressed.
Check the product label for the lot number #TX5274 and expiration date 09/30/2026. If it matches, contact Apotex for instructions.
The recall is for potential bacterial contamination, which could cause infections in vulnerable individuals. There is no mention of immediate physical injury risks in normal use.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-0326-2024 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-0326-2024 from Apotex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
