Drug product
LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
D-1383-2012
Product summary
- Firm
- Linde Gas LLC
- Event
- Event 61917
- Status
- Terminated
- Classification
- Class II
- Quantity
- 283 cylinders
- Official record key
drug-enforcement:D-1383-2012
Official wording
Reason: CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Code information: LOT#: 117H201 LOT#: 117H202
Distribution pattern: Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations