CLASS II Drug recall · Reported 15 Aug 2012 · FDA Enforcement Report
Oxygen, Compressed USP Medical Gas recalled by Oklahoma Respiratory Care
Oklahoma Respiratory Care is recalling Oxygen, Compressed USP Medical Gas in the following containers: E Cylinder, D Cylinder, distributed in Oklahoma. The recall was initiated on 21 Jun 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1445-2012
- FDA event ID
- 62698
- Recalling firm
- Oklahoma Respiratory Care, Norman, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2012
- FDA classified
- 8 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 21 Jun 2012 | Recall initiated by company | |
| 8 Aug 2012 | Classified by FDA | +48 days |
| 15 Aug 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Product as listed by the FDA
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
Where it was distributed
OK
Questions about this recall
Why was it recalled?
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Which lots are affected?
All lots distributed January 1, 2011 - October 18, 2011.
Where was it sold?
OK
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Oklahoma Respiratory Care
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxygen, Compressed USP UN1072 Medical Gas supplied in a) recalled | Oklahoma Respiratory Care | Potency & Assay | OK |