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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3

D-0350-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
7490 PACKETS
Official record key
drug-enforcement:D-0350-2018

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: 6065; Lots: 51450; EXP 9/19/2017; 52551, EXP 11/30/2017; 53180, EXP 1/16/2018; 54074, EXP3/11/2018; 54855, EXP 4/28/2018; 010437, EXP1/12/2019; 020637, EXP 2/14/2019; 51256, EXP 5/27/2018; 081066, EXP 8/25/2018; 090246, EXP 9/8/2018; 110026, 11/8/2018; 110625, EXP 11/19/2017.

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