D-1107-2023 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
304 bags

Product Description

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot# 36-262315, Exp 8/21/2023; 36-262514, Exp 8/25/2023; 36-262993, Exp 8/28/2023.