Drug product
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
D-0574-2022
Product summary
- Event
- Event 89635
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,004 cans of propellent
- Official record key
drug-enforcement:D-0574-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: 33748
Distribution pattern: Product was distributed to a client in Colorado.
Derived failure modes
-
Manufacturing or process control
cGMP deviations