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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6673

D-0392-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
672 Cases
Official record key
drug-enforcement:D-0392-2018

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: 6673; Lots: 57938, EXP 09/19/2017; 59802, EXP 01/08/2018; 61329, EXP 03/05/2018.

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