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Class II · ModerateActive recall

Fluticasone Propionate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot number # TX5274 Exp. 09/30/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: potential presence of Burkholderia cepacia complex

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byApotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326 foreign manufacturer
Brand nameFLUTICASONE PROPIONATE
Generic nameFLUTICASONE PROPIONATE
Active ingredient(s)FLUTICASONE PROPIONATE
Distributed by / forApotex Corp Weston, FL 33326
NDC60505-0829-1
Show the full FDA record
Full product labelFluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Recalling firmApotex Corp.
DistributionNationwide in the USA
Quantity292,752 bottles
Recall initiated2024-02-09
Report date2024-02-28
Recall completed—
Recall numberD-0326-2024
ClassificationClass II
FDA statusOngoing
Origin on fileWeston FL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.