Recalls / Class II
Class IID-0384-2018
Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Contains 1 Suction Toothbrush with sodium Bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6572
- Affected lot / code info
- Product Code: 6572; Lots: 52349, 52367, 52370, 52438, EXP 10/03/2017; 52457, 52471, EXP 10/17/2017; 53106, EXP 11/14/2017; 53569, EXP 12/19/2017; 53945, EXP 01/30/2018; 54354, EXP 02/20/2018; 54950, EXP 03/28/2018; 55452, EXP 04/24/2018; 56131, EXP 06/12/2018; 56901, EXP 07/31/2018; 57791, EXP 09/18/2018; 58455, EXP 10/24/2018; 59447, EXP 12/11/2018; 59869, EXP 01/08/2019; 60887, EXP 03/12/2019; 61883, EXP 04/30/2019.
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
Recalling firm
- Firm
- Sage Products Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, Cary, Illinois 60013-1804
Distribution
- Quantity
- 10505 Cases
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2018-02-09
- Posted by FDA
- 2018-02-21
- Terminated
- 2018-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0384-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.