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
Product summary
- 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products