D-0381-2018 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
- 5303 Cases
Product Description
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, 2 Packages of 1 Suction Toothbrush 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 6552 UPC 6 18029 82115 7
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: 6552; Lots: 52573, 52926, 53596, EXP 10/03/2017; 53610, 54288, EXP 12/19/2017; 54723, EXP 02/27/2018; 55878, 55890, 56617, 56637, EXP 04/24/2018; 56644, 56647, 56652, 57299, 57317, EXP 06/12/2018; 57305, EXP 05/08/2018; 57321, 60919, 61943, 58386, EXP 08/07/2018; 58398, EXP 10/02/2018; 59723, EXP 10/16/2018; 59739, EXP 12/11/2018;