CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1
Recall Number: D-1035-2023
Firm: Central Admixture Pharmacy Services, Inc.
Classification: Class II
Status: Terminated
Report Date: 20230809
Initiation Date: 20230714
Termination Date: 20250328
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product Description
CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1