FDA recall D-0574-2022

Pharmasol Corporation · Class II · drug

Product

Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302

Reason for recall

cGMP deviations

Distribution

Product was distributed to a client in Colorado.

Key facts

Status
Terminated
Initiation date
2022-01-11
Report date
2022-03-02
Termination date
2023-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Easton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2022