PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 21, 2018 Initiated: August 22, 2017 #D-0359-2018

Product Description

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 for Recall

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Details

Recalling Firm
Sage Products Inc
Units Affected
835 cases
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Location
Cary, IL

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Sage Products Inc. Units affected: 835 cases.
Why was this product recalled? ▼
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Moderate. Recall number: D-0359-2018.

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