Pharmasol Lung Cleaner Saline Eucalyptus Inhaler Recall
Pharmasol Corporation is recalling Lung Cleaner (saline eucalyptus) inhalers in 37 oz cans due to current good manufacturing practice (cGMP) deviations identified during production.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for cGMP deviations without any reported illnesses or injuries. The source text does not indicate any safety incidents or harm. Class II recalls with manufacturing process deviations but no safety event history typically fall into the Moderate category.
Plain-English summary
Pharmasol Corporation is recalling 5,004 cans of Lung Cleaner (saline eucalyptus) inhaler (37 oz cans) manufactured for The Lung Cleaner LLC in Boulder, Colorado. The recall was initiated on January 11, 2022, and classified as Class II by the FDA on February 22, 2022.
The product is being recalled due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and was initiated by the firm after notification by telephone.
The product was distributed to a client in Colorado. Lot #33748 is affected by this recall.
If you have this product, contact Pharmasol Corporation with questions. The recall was terminated on June 22, 2023.
The recalled product
- Product
- Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
- Manufacturer
- Pharmasol Corporation
- Category
- Drug — Inhaler
- Affected units
- 5,004
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 33748
Distribution
Distributed in 1 state:
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