Drug product
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
D-1445-2012
Product summary
- Event
- Event 62698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 861 cylinders
- Official record key
drug-enforcement:D-1445-2012
Official wording
Reason: CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Code information: All lots distributed January 1, 2011 - October 18, 2011.
Distribution pattern: OK
Derived failure modes
-
Manufacturing or process control
CGMP Deviations