CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, R...
FDA Recall #D-1108-2023 — Class II — August 17, 2023
Product Description
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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
184
Distribution
Nationwide in the USA
Code Information
Lot# 36-262513, Exp 8/25/2023; 36-262880, Exp 8/27/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated