Class II Recall

Central Admixture Pharmacy Services, Inc.

Product
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
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Status
Terminated
Lot
Lot: 36-253948, Exp. 7/20/2023; 36-255217, Exp. 7/23/2023.
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.