CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag,...
FDA Recall #D-1110-2023 — Class II — August 17, 2023
Product Description
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
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
84 bags
Distribution
Nationwide in the USA
Code Information
Lot# 36-262516, Exp 8/25/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated