CLASS II Drug recall · Reported 5 May 2021 · FDA Enforcement Report
Oxygen, Compressed, USP UN recalled by Grace Healthcare Medical
Grace Healthcare Medical is recalling Oxygen, Compressed, USP UN 1072, distributed nationwide in the US. The recall was initiated on 15 Apr 2021 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-0355-2021
- FDA event ID
- 87742
- Recalling firm
- Grace Healthcare Medical, Gulfport, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2021
- FDA classified
- 26 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 15 Apr 2021 | Recall initiated by company | |
| 26 Apr 2021 | Classified by FDA | +11 days |
| 5 May 2021 | Published in enforcement report | +9 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
Product as listed by the FDA
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331
Where it was distributed
USA Nationwide
Questions about this recall
Is Oxygen, Compressed, USP UN 1072 recalled?
Yes. Grace Healthcare Medical recalled Oxygen, Compressed, USP UN 1072 on 15 Apr 2021. The recall is Class II and its status is Terminated. Recall number D-0355-2021.
Why was it recalled?
cGMP deviations
Which lots are affected?
All lots manufactured and distributed 04/01/2019-04/09/2021
Where was it sold?
USA Nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.