D-1109-2023 Class II Terminated

Recalled by Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Recall Details

Product Type
Drugs
Report Date
September 6, 2023
Initiation Date
August 17, 2023
Termination Date
March 27, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84 bags

Product Description

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1

Reason for Recall

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Distribution Pattern

Nationwide in the USA

Code Information

Lot# 36-262515, Exp 8/25/2023.