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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570

D-0382-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
6472 Cases
Official record key
drug-enforcement:D-0382-2018

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: 6570; Lots: 51571, EXP 08/15/2017; 52105, EXP 09/19/2017; 53077, EXP 11/14/2017; 54259, EXP 02/06/2018; 55243, 04/10/2018; 56167, EXP 06/12/2018; 56874, EXP 07/31/2018; 57748, EXP 09/18/2018; 59258, EXP 11/20/2018; 60144, EXP 11/27/2018; 61149, EXP 03/26/2019; 62084, EXP 05/14/2019.

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