Drug product
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331
D-0355-2021
Product summary
- Event
- Event 87742
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,838 cylinders
- Official record key
drug-enforcement:D-0355-2021
Official wording
Reason: cGMP deviations
Code information: All lots manufactured and distributed 04/01/2019-04/09/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations