Class II · Moderate risk Terminated
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family…
Reason cGMP Deviations
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D…
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
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Class II · Moderate risk Terminated
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D…
Reason cGMP deviations
Class II · Moderate risk Terminated
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk Terminated
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by…
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…
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