Drug product
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6808 UPC 6 18029 84122 3
D-0397-2018
Product summary
- Event
- Event 77992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2468 Cases
- Official record key
drug-enforcement:D-0397-2018
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: 6808; Lots: 57592, EXP 08/14/2017; 58202, EXP 10/02/2017; 59213, EXP 11/13/2017; 60274, EXP 01/02/2018; 60718 EXP 02/05/2018; 61745, EXP 03/21/2018.
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