Drug product
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
D-1060-2017
Product summary
- Event
- Event 77760
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 lbs
- Official record key
drug-enforcement:D-1060-2017
Official wording
Reason: GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Code information: B-06324027 (AHM #E040645) Lot #: 051017V1, Exp. Date: 5/11/17
Distribution pattern: NJ
Derived failure modes
-
Manufacturing or process control
GMP Deviations