FDA Drug recall D-0355-2018
Toothette 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 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-0355-2018 |
| 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 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
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: 6002; Lots: Product Code: 6002; Lots: 52149, EXP 08/04/2017; 52982, EXP 09/21/2017; 53942, 54042, EXP 01/…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. |
|---|
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-0355-2018%22
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