Drug recall: UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-0
FDA enforcement event 72252 is a drug recall by Praxair Inc. of Danbury, CT, initiated 16 Sep 2015 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 31% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 10 May 2016. Initiation: voluntary: firm initiated. Praxair Inc. has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Praxair Inc., Danbury, CT.
Reason for recall
"CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0782-2016 | UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006. | 127 cylinders | Class III | Terminated | 6 Apr 2016 |
| D-0783-2016 | UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, | 382 cylinders | Class III | Terminated | 6 Apr 2016 |
Context
Other enforcement events for Praxair Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Nov 2012 | Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pres (63729) | Device | Class I | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.