Toothette Oral Care Single Use System With Perox-A-Mint solution — Class II drug recall D-0364-2018
Terminated recall by Sage Products Inc, reported 2018-02-21, distributed nationwide. Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on eq
| Recall number | D-0364-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products Inc, Cary, IL, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IE, NL, NZ |
| Quantity | 14,753 cases |
| UPC / GTIN / UDI-DI | 00618029800077 |
| Lot numbers | 51502, 51883, 53585, 54222, 54226, 54811, 55574, 56190, 56346, 56616, 57066, 57873, 58634, 58664, 59719, 61340, 62326 |
| Expiration dates | 2017-08-15, 2018-02-06, 2018-03-21, 2018-05-08, 2018-06-12, 2018-06-26, 2018-07-12, 2018-08-07, 2018-08-28, 2018-09-25, 2018-11-06, 2018-12-19, 2019-01-02, 2019-04-02, 2019-06-11 |
Product
Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0364-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.