CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume ...
FDA Recall #D-1033-2023 — Class II — July 14, 2023
Product Description
CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
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
80 bags.
Distribution
Nationwide in the USA
Code Information
Lot:36-255214, Exp.7/23/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated