D-0358-2018 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
- 2,429 cases
Product Description
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001, UPC (01)00618029800039
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: 6001; Lots: 52267, EXP 08/04/2017; 52278, 52974, 09/21/2017; 53633, 53661, 53663, 53667, EXP 12/06/2017; 54107, EXP 01/19/2018; 55208, EXP 04/25/2018; 56290, EXP 11/19/2017; 56815, EXP 05/27/2018; 57889, EXP 09/08/2018; 58819 EXP 09/14/2018; 59332, EXP 09/22/2018; 60214, EXP 11/22/2018; 61607, EXP 01/23/2019; 62124, EXP 02/14/2019.