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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 #: TX5275, Exp. Date: 10/31/2026.
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:Suspected 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 byApotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA
Brand nameFLUTICASONE PROPIONATE
Generic nameFLUTICASONE PROPIONATE
Active ingredient(s)FLUTICASONE PROPIONATE
Distributed by / forGolden State Medical Supply Inc.
NDC60429-195-15
Show the full FDA record
Full product labelFluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
Recalling firmGolden State Medical Supply Inc.
DistributionNationwide in the USA
Quantity59,712 bottles
Recall initiated2024-02-14
Report date2024-03-06
Recall completed—
Recall numberD-0349-2024
ClassificationClass II
FDA statusOngoing
Origin on fileCamarillo CA 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.