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Recall Observatory FDA recall evidence

Drug product

Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1

D-0372-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
2,938 cases
Official record key
drug-enforcement:D-0372-2018

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: 6308; Lots: 55134, EXP 08/28/2017, 56144, 56521, EXP 09/26/2017; 57495, EXP 11/13/2017; 58716, EXP 04/03/2018; 59486, EXP 06/15/2018; 59504, EXP 07/16/2018; 60426, EXP 08/02/2018; 61665,EXP 10/16/2018; 62033, 62058, EXP 11/12/2018.

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