Why it was recalled
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Product description
Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5
Lot numbers, UPCs & expiration codes
Lots:52115, EXP 08/04/2017; 52284, 52631, 53005, EXP 09/21/2017; 53012, 53343, EXP 12/02/2017; 53475, 53754, EXP 12/06/2017; 53765, 54130, 54146, 54158, 54166, 54179, 54502, EXP 01/19/2018; 54518, 54658, 54984, EXP 03/08/2018; 55063, 55540, 56029, EXP 04/25/2018; 56308, 56427, EXP 11/19/2017; 56442, 56620, EXP 05/27/2018; 56713, EXP 04/25/2018; 56737, 57067, 57325, EXP 05/27/2018; 57531, EXP 08/25/2018; 57932, 58115, EXP 09/08/2018; 58712, EXP 04/25/2018; 58757, 59015, EXP 09/14/2018; 59086, 59518, EXP 09/22/2018; 59565, 59764, EXP 11/22/2018; 60101, 60582, EXP 12/19/2018; 60637, EXP 01/23/2019; 61184, EXP 05/27/2018; 61195, 61654, EXP 01/23/2019;
Where it was sold
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
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-0360-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 25,409 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0360-2018, exactly as published.
Show all FDA fields
- City
- Cary
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77992
- Address
- 3909 3 Oaks Rd
- Code information
- Lots:52115, EXP 08/04/2017; 52284, 52631, 53005, EXP 09/21/2017; 53012, 53343, EXP 12/02/2017; 53475, 53754, EXP 12/06/2017; 53765, 54130, 54146, 54158, 54166, 54179, 54502, EXP 01/19/2018; 54518, 54658, 54984, EXP 03/08/2018; 55063, 55540, 56029, EXP 04/25/2018; 56308, 56427, EXP 11/19/2017; 56442, 56620, EXP 05/27/2018; 56713, EXP 04/25/2018; 56737, 57067, 57325, EXP 05/27/2018; 57531, EXP 08/25/2018; 57932, 58115, EXP 09/08/2018; 58712, EXP 04/25/2018; 58757, 59015, EXP 09/14/2018; 59086, 59518, EXP 09/22/2018; 59565, 59764, EXP 11/22/2018; 60101, 60582, EXP 12/19/2018; 60637, EXP 01/23/2019; 61184, EXP 05/27/2018; 61195, 61654, EXP 01/23/2019;
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0360-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 25,409 cases
- Termination date
- Dec 13, 2018
- Reason for recall
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2018