Drug product
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, , 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594-S UPC 6 18029 82134 1
D-0388-2018
Product summary
- Event
- Event 77992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 Cases
- Official record key
drug-enforcement:D-0388-2018
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: 6594-S; Lots:52348, EXP 08/08/2017.
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