D-0379-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- August 22, 2017
- Termination Date
- December 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,628 cases
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
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
Distribution Pattern
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
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.