FDA Recalls Fluticasone Propionate Nasal Spray Due to Suspected Bacterial Contamination
The FDA is recalling Fluticasone Propionate Nasal Spray due to suspected potential presence of Burkholderia cepacia complex bacteria. The affected lot (TX5275) was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving suspected bacterial contamination in a prescription drug. The presence of Burkholderia cepacia is characterized as suspected and potential in the source text, with no reported illnesses or injuries. Per the rubric, high-risk pathogens without reported illness qualify as High (3).
Plain-English summary
Golden State Medical Supply Inc. is recalling Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (16 g net fill, 120 metered sprays), NDC 60429-195-15, manufactured by Apotek Inc. The affected lot is TX5275 with an expiration date of 10/31/2026. A total of 59,712 bottles of this prescription medication have been distributed.
The recall was initiated due to current good manufacturing practice (CGMP) deviations involving suspected potential presence of Burkholderia cepacia complex.
The affected product was distributed nationwide across the United States.
Patients currently using this medication should contact their healthcare provider or pharmacist for guidance. Do not discard this medication without consulting a healthcare professional, as they can advise on appropriate alternatives or next steps.
The recalled product
- Product
- FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
- Brand
- FLUTICASONE PROPIONATE
- Manufacturer
- Golden State Medical Supply Inc.
- Hazard
- burkholderia-cepacia
- bacterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: TX5275
- Exp. Date: 10/31/2026.
Distribution
Distributed nationwide across the United States.
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