Drugplain

Fluticasone Propionate 50 ug/1

Fluticasone Propionate · SPRAY, METERED · Sam's West, Inc

10 Recalls on RecordCurrently in Shortage
Plain English

Fluticasone Propionate is a spray, metered containing fluticasone propionate at 50 ug/1, taken nasal. Manufactured by Sam's West, Inc.

Key Facts

Brand Name
Fluticasone Propionate
Generic Name
Fluticasone Propionate
NDC Code (Product)
68196-503
Manufacturer
Sam's West, Inc
Strength
50 ug/1
Dosage Form
SPRAY, METERED
Route
NASAL
Marketing Status
Application #
ANDA208150
Marketing Start
07/01/2025

Recall History

10 Recalls on Record
Class II02/27/2015

Akorn, Inc.

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

TerminatedVoluntary: Firm initiated
Class II02/01/2019

Mylan Pharmaceuticals Inc.

Defective Container: Potential for broken glass in the neck area of the glass bottles.

TerminatedVoluntary: Firm initiated
Class II09/22/2021

Teva Pharmaceuticals USA

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II02/14/2024

Golden State Medical Supply Inc.

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

OngoingVoluntary: Firm initiated
Class II06/13/2022

Akorn, Inc.

Defective container: defect prevents product from dispensing as intended.

TerminatedVoluntary: Firm initiated
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated
Class II09/22/2021

Teva Pharmaceuticals USA

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

TerminatedVoluntary: Firm initiated
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated
Class III10/24/2012

GlaxoSmithKline, LLC.

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product dose omission issue2,967 reports
dyspnoea2,543 reports
drug ineffective2,524 reports
headache2,240 reports
fatigue2,111 reports
off label use2,103 reports
pain1,850 reports
nausea1,823 reports
cough1,766 reports
asthma1,707 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy, watery eyes itchy nose runny nose sneezing

Dosage & Administration

Directions read the Quick Start Guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1- use 2 sprays in each nostril once daily Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 TO 11 YEARS OF AGE the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. an adult should supervise use use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE do not use

Warnings

Warnings Only for use in the nose. Do not spray into your eyes or mouth.

Frequently Asked Questions

What is Fluticasone Propionate used for?

Fluticasone Propionate contains Fluticasone Propionate. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is Fluticasone Propionate a controlled substance?

Fluticasone Propionate is not classified as a controlled substance by the DEA.

What is the generic name for Fluticasone Propionate?

The generic name for Fluticasone Propionate is Fluticasone Propionate. There are 8 other brand versions of Fluticasone Propionate.

What is the NDC code for Fluticasone Propionate 50 ug/1?

The NDC (National Drug Code) for Fluticasone Propionate 50 ug/1 is 68196-503, listed by Sam's West, Inc.