D-0361-2018 Class II Terminated
FDA drug recall D-0361-2018 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: 849 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
- 849 cases
Product Description
Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002-D UPC (01)00618029821461
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: 6002-D; Lots: 57942, EXP 09/08/2018; 58186, 58673, EXP 09/14/2018; 60297, EXP 12/19/2018; 61893, EXP 02/14/2019.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0361-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026