D-1108-2023 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
184

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot# 36-262513, Exp 8/25/2023; 36-262880, Exp 8/27/2023