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 Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513
Lot numbers, UPCs & expiration codes
Product Code: 6513; Lots: 51175, 51220, EXP 08/01/2017; 51570, EXP 08/15/2017; 51786, EXP 08/29/2017; 52104, EXP 09/19/2017; 52550, 52570,EXP 10/17/2017; 53460, EXP 12/12/2017, 53922, EXP 1/16/2018; 54161,EXP 02/06/2018; 54294, EXP 02/15/2018; 54395, EXP 02/20/2018; 54459,EXP 02/27/2018; 54963, EXP 03/28/2018; 54992, 55040, 55049, 55060, 55070, EXP 4/3/2018; 55486, 55617, EXP 05/08/2018; 56210, EXP 06/19/2018; 56772, 56777, EXP 07/24/2018; 57105, EXP 08/14/2018; 57329, EXP 08/21/2018; 57507, EXP09/05/2018; 58173, EXP 10/09/2018; 58429, EXP 10/24/2018; 59037, EXP 11/13/2018; 59549, EXP 12/11/2018; 59920, EXP 01/15/2019; 60566, EXP 02/19/2019; 60863, EXP 03/05/2019; 61292, EXP 04/02/2019; 61980, EXP 05/07/2019.
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-0379-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 42,628 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0379-2018, 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
- Product Code: 6513; Lots: 51175, 51220, EXP 08/01/2017; 51570, EXP 08/15/2017; 51786, EXP 08/29/2017; 52104, EXP 09/19/2017; 52550, 52570,EXP 10/17/2017; 53460, EXP 12/12/2017, 53922, EXP 1/16/2018; 54161,EXP 02/06/2018; 54294, EXP 02/15/2018; 54395, EXP 02/20/2018; 54459,EXP 02/27/2018; 54963, EXP 03/28/2018; 54992, 55040, 55049, 55060, 55070, EXP 4/3/2018; 55486, 55617, EXP 05/08/2018; 56210, EXP 06/19/2018; 56772, 56777, EXP 07/24/2018; 57105, EXP 08/14/2018; 57329, EXP 08/21/2018; 57507, EXP09/05/2018; 58173, EXP 10/09/2018; 58429, EXP 10/24/2018; 59037, EXP 11/13/2018; 59549, EXP 12/11/2018; 59920, EXP 01/15/2019; 60566, EXP 02/19/2019; 60863, EXP 03/05/2019; 61292, EXP 04/02/2019; 61980, EXP 05/07/2019.
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0379-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 42,628 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 Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513
- 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