Drugplain

Oxygen 99 L/100L

Oxygen · GAS · Buckeye Home Health Center, Inc.

10 Recalls on Record
Plain English

Oxygen is a gas containing oxygen at 99 L/100L, taken respiratory (inhalation). Manufactured by Buckeye Home Health Center, Inc..

Key Facts

Brand Name
Oxygen
Generic Name
Oxygen
NDC Code (Product)
67493-0009
Manufacturer
Buckeye Home Health Center, Inc.
Strength
99 L/100L
Dosage Form
GAS
Route
RESPIRATORY (INHALATION)
Marketing Status
Marketing Start
09/26/2002

Recall History

10 Recalls on Record
Class II12/05/2012

Oklahoma Respiratory Care Inc

Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.

TerminatedVoluntary: Firm initiated
Class II10/10/2013

Airgas Medical Services

Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

TerminatedVoluntary: Firm initiated
Class II07/05/2016

Let's Talk Health, Inc.

Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.

TerminatedVoluntary: Firm initiated
Class II06/21/2012

Oklahoma Respiratory Care Inc

CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation

TerminatedVoluntary: Firm initiated
Class II11/29/2015

AGA Gas Inc

cGMP Deviations; trailer may not have met GMP requirements prior to filling

TerminatedVoluntary: Firm initiated
Class II05/11/2017

AtHome Medical, Inc.

GMP Deviations: The firm does not include an SOP for testing for out of specifications.

TerminatedVoluntary: Firm initiated
Class II12/19/2018

Roberts Home Medical LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III02/05/2016

Medical Park Homecare, Inc

CGMP Deviations: Cylinders filled using out of date gauges.

TerminatedVoluntary: Firm initiated
Class II05/04/2012

Linde Gas LLC

CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.

TerminatedVoluntary: Firm initiated
Class II04/15/2021

Grace Healthcare Medical, Inc

cGMP deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea9,354 reports
cough4,598 reports
headache4,463 reports
diarrhoea3,986 reports
fatigue3,907 reports
pneumonia3,761 reports
nausea3,724 reports
dizziness3,229 reports
oxygen saturation decreased2,899 reports
death2,498 reports

Full Prescribing Information

Full prescribing information not available for this product.

Frequently Asked Questions

What is Oxygen used for?

Oxygen contains Oxygen. It is a gas taken respiratory (inhalation). Consult your doctor for specific uses.

Is Oxygen a controlled substance?

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

What is the generic name for Oxygen?

The generic name for Oxygen is Oxygen. There are 1 other brand versions of Oxygen.

What is the NDC code for Oxygen 99 L/100L?

The NDC (National Drug Code) for Oxygen 99 L/100L is 67493-0009, listed by Buckeye Home Health Center, Inc..

Product NDC

67493-0009

Package NDC

67493-0009-1

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

Data from openFDA · Public domain (CC0 1.0)