FDAClass IIMarch 6, 2024

Fluticasone Propionate Nasal Spray USP recall: CGMP Deviations

Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario…

Why was Fluticasone Propionate Nasal Spray USP recalled?

CGMP Deviations:Suspected 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 #: TX5275, Exp. Date: 10/31/2026.

Product
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario…
Recalling firm
Golden State Medical Supply Inc.
Quantity
59,712 bottles
Distribution
Nationwide in the USA
Recall date
March 6, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls