CLASS III Drug recall · Reported 6 Apr 2016 · FDA Enforcement Report
UN1002 Air, Compressed, Breathing Grade recalled by Praxair
Praxair is recalling UN1002 Air, Compressed, Breathing Grade, USP, distributed nationwide in the US. The recall was initiated on 16 Sep 2015 and the FDA has classified it as Class III.
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-0782-2016
- FDA event ID
- 72252
- Recalling firm
- Praxair, Danbury, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Sep 2015
- FDA classified
- 28 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 16 Sep 2015 | Recall initiated by company | |
| 28 Mar 2016 | Classified by FDA | +194 days |
| 6 Apr 2016 | 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: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Product as listed by the FDA
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
Where it was distributed
Nationwide
Questions about this recall
Is UN1002 Air, Compressed, Breathing Grade, USP recalled?
Yes. Praxair recalled UN1002 Air, Compressed, Breathing Grade, USP on 16 Sep 2015. The recall is Class III and its status is Terminated. Recall number D-0782-2016.
Why was it recalled?
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Which lots are affected?
Lot # P411517501, P411517601, P411517701, P411518001, P411518101, P411518201, P411518202, P411518301, P411518701, P411518801, P411518901, P411519101, P411519401, P411519601, P411519602, P411519701, P411520101, P411520301, P411520401, P411520901, P411521001, P411521002, P411521101, P411521201, P411521501, P411521601, P411521701, P411521801, P411521901, P411522201, P411522401, P411522501, P411522901, P411523001, P411523101, P411523201, P411523301, P411523601, P411523701, P411523801, P411523901, P411524001, P411524301,
Where was it sold?
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Praxair
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | UN1002 Air, Compressed, Medical Air recalled by Praxair | Praxair | Manufacturing (CGMP) Deviations | Nationwide |
| Device | CLASS I | Vantage Grab n Go - Gas Cylinder pressure regulator recalled by Praxair | Praxair | Other | Nationwide |