CLASS II Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) recalled
Oklahoma Respiratory Care is recalling Oxygen, Compressed USP UN1072 Medical Gas supplied in a) and b) cylinders, distributed in Oklahoma. The recall was initiated on 5 Dec 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-818-2013
- FDA event ID
- 65621
- Recalling firm
- Oklahoma Respiratory Care, Norman, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2012
- FDA classified
- 24 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Potency & Assay
Timeline
| 5 Dec 2012 | Recall initiated by company | |
| 24 Jul 2013 | Classified by FDA | +231 days |
| 31 Jul 2013 | 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
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
Where it was distributed
Oklahoma
Questions about this recall
Why was it recalled?
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Which lots are affected?
Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.
Where was it sold?
Oklahoma
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 Medical Gas recalled by Oklahoma Respiratory Care | Oklahoma Respiratory Care | Manufacturing (CGMP) Deviations | OK |