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
Recall Number: D-1109-2023
Firm: Central Admixture Pharmacy Services, Inc.
Classification: Class II
Status: Terminated
Report Date: 20230906
Initiation Date: 20230817
Termination Date: 20250327
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Product Description
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