Drug product
Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 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 6006 UPC (01)00618029800053
D-0363-2018
Product summary
- Event
- Event 77992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 637 cases
- Official record key
drug-enforcement:D-0363-2018
Official wording
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Code information: Product Code: 6006; Lots: 54523,54629, 55528, EXP 02/06/2018; 56864, 57915, EXP 04/12/2018; 58884, 60137, 61047, EXP 05/23/2018; 61123, EXP 02/10/2019
Distribution pattern: Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Derived failure modes
-
Unknown
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products