Drugplain

Air 995 mL/L

Air · GAS · Westair Gases & Equipment, Inc.

10 Recalls on Record
Plain English

Air is a prescription gas inhaled through the respiratory system that contains 995 mL/L strength. This medication is used as a breathing gas for patients who require respiratory support.

Key Facts

Brand Name
Air
Generic Name
Air
NDC Code (Product)
53440-007
Manufacturer
Westair Gases & Equipment, Inc.
Strength
995 mL/L
Dosage Form
GAS
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA205767
Marketing Start
01/01/2000

Recall History

10 Recalls on Record
Class III03/10/2015

Matheson, Inc.

Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class III09/16/2015

Praxair Inc.

CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class III09/16/2015

Praxair Inc.

CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II01/25/2024

Alpha Aromatics

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea10,254 reports
toxicity to various agents6,737 reports
drug abuse5,927 reports
completed suicide5,767 reports
headache5,197 reports
cough5,077 reports
nausea4,811 reports
fatigue4,778 reports
diarrhoea4,699 reports
death4,644 reports

Full Prescribing Information

Full prescribing information not available for this product.

Frequently Asked Questions

What is Air used for?

Air is a prescription gas inhaled through the respiratory system that contains 995 mL/L strength. This medication is used as a breathing gas for patients who require respiratory support.

Is Air a controlled substance?

Air is not classified as a controlled substance by the DEA.

What is the generic name for Air?

The generic name for Air is Air. There are 2 other brand versions of Air.

What is the NDC code for Air 995 mL/L?

The NDC (National Drug Code) for Air 995 mL/L is 53440-007, listed by Westair Gases & Equipment, Inc..

Product NDC

53440-007

Package NDC

53440-007-06

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)