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Recall Observatory FDA recall evidence

Drug product

Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6504. UPC 6 18029 83045 6

D-0356-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
2,199 cases
Official record key
drug-enforcement:D-0356-2018

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: 6504; Lots: 58174, EXP 09/11/2017; 59297, EXP 11/13/2017; 60127, EXP 01/02/2018; 60673, EXP 02/05/2018; 61002, EXP 02/23/2018; 61817, EXP 03/21/2018; 61825, EXP 04/27/2018

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