D-0369-2018 Class II Terminated
FDA drug recall D-0369-2018 was initiated by Sage Products Inc on Aug 22, 2017 and is designated Class II. 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 The recall status is terminated (terminated Dec 13, 2018). Affected quantity: 879 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2018
- Initiation Date
- Aug 22, 2017
- Termination Date
- Dec 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 879 cases
Product Description
Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990
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: 6113; Lots: 57874, EXP 09/19/2017; 58903, EXP 11/15/2017; 60045, EXP 01/08/2018; 61109, EXP 01/22/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0369-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026