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Recall Observatory FDA recall evidence

Drug product

UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

D-0783-2016

September 16, 2015

Class III

Product summary

Firm
Praxair Inc.
Event
Event 72252
Status
Terminated
Classification
Class III
Quantity
382 cylinders
Official record key
drug-enforcement:D-0783-2016

Official wording

Reason: CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Code information: Lot # K411517501, K411517601, K411517701, K411518001, K411518101, K411518201, K411518202, K411518301, K411518302, K411518701, K411518801, K411518901, K411518902, K411519001, K411519101, K411519401, K411519501, K411519601, K411519602, K411519701, K411519801, K411520101, K411520201, K411520301, K411520302, K411520401, K411520901, K411521001, K411521002, K411521101, K411521102, K411521201, K411521501, K411521601, K411521602, K411521701, K411521702, K411521801, K411521901, K411522201, K411522301, K411522401, K411522501, K411523001, K411523101, K411523201, K411523202, K411523301, K411523601, K411523701, K411523801, K411523901, K411523902, K411524001, K411524301, K411524302, K411524401, K411522601, K411522901,

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations