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 Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
Lot numbers, UPCs & expiration codes
Product Code: 6512; Lots: 51381, EXP 8/8/2017; 51433, 51453, EXP 8/15/2017; 51931, EXP 9/12/17; 52754 EXP 10/31/2017; 53326, EXP 11/28/2017; 53826, EXP 1/9/2018; 54266, EXP /15/2018; 54606, EXP 3/6/2018; 54872, EXP 3/21/2018; 55310, 55319, EXP 4/17/2018; 55823, EXP 5/22/2018; 56030, EXP 6/5/2018; 56039, EXP 5/30/2018; 56054, EXP 6/5/2018; 56385, 56408, 56417, EXP 6/26/2018; 56424, 56432, 56440, 56450, EXP 7/5/2018; 56828, EXP 7/27/2018; 57436, EXP 8/29/2018; 57860, EXP 9/25/2018; 58010, EXP 10/2/2018; 58126, EXP 10/9/2018; 58753 EXP 11/6/2018; 59089, 59129, 59143, EXP 11/13/2018; 59762, EXP 1/2/2019; 60261, 60308, EXP 1/22/2019; 60957, EXP 3/12/2019; 61411 EXP 4/9/2019; 61715, EXP 4/23/2019.
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-0353-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 38,792 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0353-2018, 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: 6512; Lots: 51381, EXP 8/8/2017; 51433, 51453, EXP 8/15/2017; 51931, EXP 9/12/17; 52754 EXP 10/31/2017; 53326, EXP 11/28/2017; 53826, EXP 1/9/2018; 54266, EXP /15/2018; 54606, EXP 3/6/2018; 54872, EXP 3/21/2018; 55310, 55319, EXP 4/17/2018; 55823, EXP 5/22/2018; 56030, EXP 6/5/2018; 56039, EXP 5/30/2018; 56054, EXP 6/5/2018; 56385, 56408, 56417, EXP 6/26/2018; 56424, 56432, 56440, 56450, EXP 7/5/2018; 56828, EXP 7/27/2018; 57436, EXP 8/29/2018; 57860, EXP 9/25/2018; 58010, EXP 10/2/2018; 58126, EXP 10/9/2018; 58753 EXP 11/6/2018; 59089, 59129, 59143, EXP 11/13/2018; 59762, EXP 1/2/2019; 60261, 60308, EXP 1/22/2019; 60957, EXP 3/12/2019; 61411 EXP 4/9/2019; 61715, EXP 4/23/2019.
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0353-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 38,792 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 Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
- 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