Drug product
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
D-818-2013
Product summary
- Event
- Event 65621
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94 cylinders
- Official record key
drug-enforcement:D-818-2013
Official wording
Reason: Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Code information: Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.
Distribution pattern: Oklahoma
Derived failure modes
-
Potency or specification failure
out of specification