Fluticasone Propionate Nasal Spray Recalled for Potential Bacterial Contamination
Apotex Corp. is recalling Fluticasone Propionate Nasal Spray (292,752 bottles nationwide) due to potential Burkholderia cepacia contamination from manufacturing deviations. No illnesses reported.
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 designation with potential presence of Burkholderia cepacia complex, a high-risk pathogen. No illnesses or injuries have been reported, and the contamination is potential rather than confirmed. This meets the rubric criterion of high-risk pathogens without reported illness.
Plain-English summary
Apotex Corp. is recalling Fluticasone Propionate Nasal Spray USP 50 mcg (120 metered sprays, 16 g net fill). The affected lot is TX5274 with expiration date 09/30/2026 (NDC 60505-0829-1). Approximately 292,752 bottles were distributed nationwide in the United States.
The recall was initiated due to current good manufacturing practice (CGMP) deviations that resulted in the potential presence of Burkholderia cepacia complex in the recalled product.
Patients using this medication should consult their healthcare provider regarding the recall. Those with bottles from lot TX5274 should discontinue use and contact Apotex Corp. or their pharmacy with the recalled product.
No illnesses or injuries related to the recalled product have been reported.
The recalled product
- Product
- FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
- Brand
- FLUTICASONE PROPIONATE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Nasal Spray
- 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 (1)
- Lot number # TX5274 Exp. 09/30/2026
Distribution
Distributed nationwide across the United States.
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