CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1

Recall Number: D-1021-2023

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, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1