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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4

D-0357-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
4,061 cases
Official record key
drug-enforcement:D-0357-2018

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: 6122; Lots: 020387, EXP 02/13/2019; 041657, EXP 05/03/2019; 010507, EXP 01/16/2019; 050926, EXP 05/24/2018; 081026, EXP 08/24/2018; 090636, EXP 09/26/2018; 100176, 10/11/2018; 110575, EXP 11/24/2017; 10786, EXP 11/23/2018; 120936, EXP 12/21/2018. 110575

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