Drug product
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
D-0106-2024
Product summary
- Event
- Event 93418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,657 Cylinders
- Official record key
drug-enforcement:D-0106-2024
Official wording
Reason: cGMP Deviations
Code information: All lots manufactured and distributed May 10, 2023, through October 31, 2023.
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations