Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL,
Recalled September 6, 2023 · FDA recall D-1109-2023 · Central Admixture Pharmacy Services
Hazard
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles · FDA Class II
Units
84 bags
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Manufacturer(s)
Central Admixture Pharmacy Services, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →