Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse… — Class II drug recall D-0368-2018
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-0368-2018 |
|---|---|
| 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 | 640 cases |
| Lot numbers | 58483, 59783, 61117 |
| Expiration dates | 2017-10-09, 2018-01-08, 2018-03-05 |
Product
Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code 6115
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-0368-2018. 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.