Class II Recall

Central Admixture Pharmacy Services, Inc.

Product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Status
Terminated
Lot
Lot: 36-251457, Exp. 7/14/2023; 36-253952, Exp. 7/20/2023; 36-255944, Exp. 7/27/2023; 36-257101, Exp. 7/31/2023.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Central Admixture Pharmacy Services, Inc. — Class II Recall | MedicineWatch US