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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571

D-0383-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
8466 Cases
Official record key
drug-enforcement:D-0383-2018

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: 6571; Lots: 52384, EXP 10/03/2018; 53134, EXP 11/28/2017; 53387, EXP 12/05/2017; 54215, EXP 02/06/2018; 54967, EXP 03/28/2018; 55997, EXP 05/30/2018; 56180, EXP 06/12/2018; 56854, EXP 07/31/2018; 57334, EXP 08/21/2018; 58305, EXP 10/16/2018; 59844, EXP 01/08/2019; 60753, 60761, 60772, 60780, 60788,EXP 03/05/2019; 61664, EXP 04/23/2019; 62156, 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