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; no identity or purity testing on incoming oxygen gas, and lack of documentation
What was recalled
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
- Recalling firm
- Oklahoma Respiratory Care Inc
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1445-2012
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
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.
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