FDA Drug recall D-0367-2018
Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate,…
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate,… by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0367-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sage Products |
| Distribution | US |
Product
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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Identifiers
| code_info | Product Code: 6100; Lots: 57856, 58296, 58814, EXP 11/24/2017; 54496, 55225, 56214, EXP 02/06/2018; 56280, 57109, 5828…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Sage Products
- 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013
FDA Drug · Class II · 2026-09-09 · Sage Products - stryker Sage PrimaFit External Urine Management System for the Female Anatomy
FDA Device · Class II · 2023-11-29 · Sage Products - Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System
FDA Device · Class II · 2019-08-14 · Sage Products - Oral Cleaning and Suctioning System q2
FDA Drug · Class II · 2018-02-21 · Sage Products - Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bica…
FDA Drug · Class II · 2018-02-21 · Sage Products
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0367-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.