FDAClass IIMarch 11, 2015

Fluticasone Propionate Nasal Spray recall

Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only…

Why was Fluticasone Propionate Nasal Spray recalled?

Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

What should I do if I have this product?

Review the official FDA enforcement record for current 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 #: 631639, Exp 01/2017.

Product
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only…
Recalling firm
Akorn, Inc.
Quantity
44,448 bottles
Distribution
Nationwide and Puerto Rico
Recall date
March 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls