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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077

D-0364-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
14,753 cases
Official record key
drug-enforcement:D-0364-2018

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: 6012; Lots: 51502, EXP 08/15/2017; 51883, 09/06/2017; 53585, EXP12/19/2018; 54222, 54226, EXP 02/06/2018; 54811, EXP 03/21/2018; 55574, EXP 05/08/2018; 56190, EXP 06/12/2018; 56346, EXP 06/26/2018; 56616, EXP 07/12/2018; 57066, EXP 08/07/2018; 57873, EXP 09/25/2018; 58634, EXP 08/28/2018; 58664, EXP 11/06/2018; 59719, EXP 01/02/2019; 61340, EXP 04/02/2019; 62326, EXP 06/11/2019

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