FDAFDA · Food and drugs·Recall number D-0380-2018
Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7
Published February 21, 2018 · Recall initiated: August 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sage Products Inc
- Distributor
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- Lot
- Product Code: 6550; Lots: 51590, EXP 08/15/2017; 52134, EXP 09/19/2017; 52179, EXP 09/26/2017; 52589, EXP 10/24/2017; 52966, EXP 11/07/2017; 53692, EXP 01/03/2018; 53883, EXP 01/16/2018; 54371, 54422, EXP 02/20/2018; 54622, 54677, EXP 03/06/2018; 54920, 54934, 54941, 54942, 54944, EXP 03/28/2018; 55296, EXP 04/17/2018; 55896, EXP 05/22/2018; 55925, 55934, 55951, EXP 05/30/2018; 56464, EXP 07/05/2018; 56936, EXP 08/07/2018; 57683, EXP 09/12/2018; 58244, EXP 10/16/2018; 58850, EXP 11/06/2018; 59283, EXP 11/20/2018; 59339, EXP 12/04/2018; 59636, EXP 12/18/2018; 59930, EXP 01/15/2019; 60592, 60648, EXP 02/26/2019; 60977, EXP 03/12/2019; 61022, EXP 03/19/2019; 61991, EXP 05/07/2019.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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