CLASS II Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Toothette Oral Care Short Term Oral Swab System recalled
Sage Products is recalling Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution, distributed nationwide in the US. The recall was initiated on 22 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0359-2018
- FDA event ID
- 77992
- Recalling firm
- Sage Products, Cary, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2017
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 22 Aug 2017 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +171 days |
| 21 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Questions about this recall
Is Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution recalled?
Yes. Sage Products recalled Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution on 22 Aug 2017. The recall is Class II and its status is Terminated. Recall number D-0359-2018.
Why was it recalled?
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Which lots are affected?
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
Where was it sold?
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Toothette recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Toothette Oral Care Suction Swabs with Perox-A-Mint solution recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Toothette Oral Care Suction Swab System With Antiseptic recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Toothette Oral Care Short Term Oral Swab System recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution recalled | Sage Products | Other | Nationwide |