Drug product
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
D-0782-2016
Product summary
- Firm
- Praxair Inc.
- Event
- Event 72252
- Status
- Terminated
- Classification
- Class III
- Quantity
- 127 cylinders
- Official record key
drug-enforcement:D-0782-2016
Official wording
Reason: CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Code information: 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,
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations