Skip to content
Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6671

D-0391-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
4255 Cases
Official record key
drug-enforcement:D-0391-2018

Official wording

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

Code information: Product Code: 6671; Lots: 51716, EXP 08/22/2017; 52904, EXP 11/07/2017; 53686, EXP 01/03/2018; 54601, 54617, EXP 03/06/2018; 55377, EXP 04/24/2018; 56658, 07/17/2018; 57927, EXP 09/25/2018; 58936, EXP 11/06/2018; 59805, EXP 01/08/2019; 60691, EXP 03/05/2019; 61141, EXP 03/26/2019.

Distribution pattern: Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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