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 Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990
Lot numbers, UPCs & expiration codes
Product Code: 6113; Lots: 57874, EXP 09/19/2017; 58903, EXP 11/15/2017; 60045, EXP 01/08/2018; 61109, EXP 01/22/2018.
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-0369-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 879 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0369-2018, 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: 6113; Lots: 57874, EXP 09/19/2017; 58903, EXP 11/15/2017; 60045, EXP 01/08/2018; 61109, EXP 01/22/2018.
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0369-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 879 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 Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990
- 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