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Recall Observatory FDA recall evidence

Drug product

Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152

D-0366-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
945 cases
Official record key
drug-enforcement:D-0366-2018

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: 6060; Lots: 53057, EXP 12/7/2017; 57537, 59140, 60722, EXP 5/23/2017.

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