Drug product
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 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 6804 UPC 6 18029 84121 6
D-0396-2018
Product summary
- Event
- Event 77992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5085 Cases
- Official record key
drug-enforcement:D-0396-2018
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: 6804; Lots: 57567, EXP 08/14/2017; 58163, EXP 09/11/2017; 59009, EXP 11/03/2017; 59637, EXP 11/27/2017; 60241, 60263, EXP 01/02/2018; 60631, EXP 02/05/2018; 61294,EXP 02/23/2018; 61321, EXP 03/30/2018.
Distribution pattern: Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Derived failure modes
-
Unknown
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products