Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Reason CGMP Deviations
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Reason CGMP Deviations
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