Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = ...
FDA Recall #D-1037-2023 — Class II — July 14, 2023
Product Description
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 for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
356 bags
Distribution
Nationwide in the USA
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated