Why it was recalled
cGMP deviations
Product description
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
Lot numbers, UPCs & expiration codes
Lot #: 33748
Where it was sold
Product was distributed to a client in Colorado.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0574-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 11, 2022
- FDA report date
- Mar 2, 2022
- Quantity
- 5,004 cans of propellent
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmasol Corporation
Original FDA data
Every field from FDA enforcement report D-0574-2022, exactly as published.
Show all FDA fields
- City
- South Easton
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 89635
- Address
- 1 Norfolk Ave
- Code information
- Lot #: 33748
- Postal code
- 02375-1900
- Report date
- Mar 2, 2022
- Product type
- Drugs
- Recall number
- D-0574-2022
- Classification
- Class II
- Recalling firm
- Pharmasol Corporation
- Product quantity
- 5,004 cans of propellent
- Termination date
- Jun 22, 2023
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
- Distribution pattern
- Product was distributed to a client in Colorado.
- Recall initiation date
- Jan 11, 2022
- Initial firm notification
- Telephone
- Center classification date
- Feb 22, 2022