Apotex Recalls Fluticasone Propionate Nasal Spray Due to Glass Particles
Apotex Inc. is recalling Fluticasone Propionate Nasal Spray because glass particles were found in the product. Consumers should stop using the affected lot.
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: The recall is classified as FDA Class II, and the hazard involves physical foreign matter (glass particles) which poses a risk of injury, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Apotex Inc. is recalling Fluticasone Propionate Nasal Spray, USP, 50 mcg, 120 Metered Sprays. The recall is due to the presence of a foreign substance, specifically glass particles, in the product.
The affected product is identified by Lot NJ4501 with an expiration date of 07/2020. The product is a prescription-only nasal spray manufactured by Apotex Inc. in Toronto, Ontario, Canada, and distributed nationwide.
Consumers who have this specific lot of Fluticasone Propionate Nasal Spray should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
- Brand
- FLUTICASONE PROPIONATE
- Manufacturer
- Apotex Inc.
- Category
- Drug — Nasal Spray
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: NJ4501 Exp. 07/2020
Distribution
Distributed nationwide across the United States.
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