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Recall Enforment Report D-0782-2016

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Praxair Inc., originally initiated on 09-16-2015 for the product UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006. The product was recalled due to cgmp deviations: confirmed customer compliant of odor when turning on a cylinder of medical air.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0782-201609-16-201504-06-2016Class III127 cylindersUN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.Terminated
D-0783-201609-16-201504-06-2016Class III382 cylindersUN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.Terminated