D-0355-2018 Class II Terminated
FDA drug recall D-0355-2018 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: 966 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
- 966 cases
Product Description
Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002 UPC (01)00618029820921
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; Lots: Product Code: 6002; Lots: 52149, EXP 08/04/2017; 52982, EXP 09/21/2017; 53942, 54042, EXP 01/19/2018; 54925, 54952, 54958, 54959, 54962, EXP 03/08/2018; 55872, EXP 04/25/2018; 57449, EXP 08/25/2018; 58381, EXP 09/14/2018; 59302, EXP 09/22/2018; 59765, EXP 11/22/2018; 61788, 61831 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-0355-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026