Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
Summary
The FDA issued a Class II for Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung by Pharmasol Corporation. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0574-2022
Action Date
2022-03-02
Status
Terminated
Category
drug
Product Description
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
Lot/Code Info: Lot #: 33748
Quantity Affected: 5,004 cans of propellent
Reason for Recall
cGMP deviations
Distribution
Product was distributed to a client in Colorado.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-11
Company
South Easton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 98 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pharmasol Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pharmasol Corporation have FDA actions?
This is the only FDA action we have on record for Pharmasol Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0574-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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