D-0367-2018 Class II Terminated
FDA drug recall D-0367-2018 was initiated by Sage Products Inc on August 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 December 13, 2018). Affected quantity: 2,548 cases.
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
- 2,548 cases
Product Description
Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz.14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6100 UPC (01)00618029820969
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: 6100; Lots: 57856, 58296, 58814, EXP 11/24/2017; 54496, 55225, 56214, EXP 02/06/2018; 56280, 57109, 58288, EXP 04/12/2018; 59175, 59487, 60187, EXP 05/23/2018; 58815, 59157, EXP 05/24/2018; 61262, 61740, EXP 02/10/2019.