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Recall Observatory FDA recall evidence

Drug product

QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packages with 0.25fl.oz/7mL Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and Four (4) Suction Oral Swab packages with 0.25 fl.oz/7mL Corinze Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6464 UPC 6 18029 83077 7

D-0351-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
1680 KITS
Official record key
drug-enforcement:D-0351-2018

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: 6464; Lots: 55175 EXP 8/28/2017; 57086, 58011, EXP 11/13/2017; 58604, EXP 4/3/2018; 60373, EXP 8/2/2018; 60590, EXP 9/4/2018; 61540, EXP 10/16/2018.

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