CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1

Recall Number: D-1038-2023

Firm: Central Admixture Pharmacy Services, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230809

Initiation Date: 20230714

Termination Date: 20250328

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1