Oxygen 99 L/100L
Oxygen · GAS · Specialty Medical Products, Inc.
Oxygen is a prescription gas that you inhale to increase oxygen levels in your blood when your body is not getting enough oxygen on its own. It is used to treat conditions like chronic lung disease, heart failure, and other medical conditions where oxygen therapy is needed.
Key Facts
- Brand Name
- Oxygen
- Generic Name
- Oxygen
- NDC Code (Product)
84228-001- Manufacturer
- Specialty Medical Products, Inc.
- Strength
- 99 L/100L
- Dosage Form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Marketing Start
- 04/02/2024
Recall History
Oklahoma Respiratory Care Inc
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
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.
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.
Oklahoma Respiratory Care Inc
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
AGA Gas Inc
cGMP Deviations; trailer may not have met GMP requirements prior to filling
AtHome Medical, Inc.
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Roberts Home Medical LLC
CGMP Deviations
Medical Park Homecare, Inc
CGMP Deviations: Cylinders filled using out of date gauges.
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.
Grace Healthcare Medical, Inc
cGMP deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Full prescribing information not available for this product.
Frequently Asked Questions
What is Oxygen used for?
Oxygen is a prescription gas that you inhale to increase oxygen levels in your blood when your body is not getting enough oxygen on its own. It is used to treat conditions like chronic lung disease, heart failure, and other medical conditions where oxygen therapy is needed.
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 84228-001, listed by Specialty Medical Products, Inc..