Class II · Moderate risk Terminated
Oxygen
Reason cGMP Deviations
Oxygen
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
- Recalling firm
- Roberts Home Medical LLC
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1002-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Oxygen recalls
See all
Class II · Moderate risk Terminated
Oxygen
Reason cGMP deviations
Class II · Moderate risk Terminated
Oxygen Refrigerated Liquid USP UN 1073
Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk Terminated
Oxygen Nasal Wash
Reason 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.
Class III · Low risk Terminated
Oxygen
Reason CGMP Deviations: Cylinders filled using out of date gauges.
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