FDA Drug recall D-0359-2018
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution
- 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 Perox-A- Mint solution 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-0359-2018 |
| 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 Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001-D NDC: 53462-024-30
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: 6001-D; Lots: 52414, 53322, EXP 09/21/2017; 53336, EXP 12/02/2017; 53673, EXP 12/06/2017; 54438, EXP 01/1…Product Code: 6001-D; Lots: 52414, 53322, EXP 09/21/2017; 53336, EXP 12/02/2017; 53673, EXP 12/06/2017; 54438, EXP 01/19/2018; 54932, EXP 03/08/2018; 55506, EXP 04/25/2018; 2015323-01, EXP 09/21/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0359-2018%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.