FDAClass IIFebruary 28, 2024

Fluticasone Propionate Nasal Spray USP 50mcg recall: CGMP Deviations

Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L…

Why was Fluticasone Propionate Nasal Spray USP 50mcg recalled?

CGMP Deviations: potential presence of Burkholderia cepacia complex

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number # TX5274 Exp. 09/30/2026

Product
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L…
Recalling firm
Apotex Corp.
Quantity
292,752 bottles
Distribution
Nationwide in the USA
Recall date
February 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls