D-1022-2023 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
August 9, 2023
Initiation Date
July 14, 2023
Termination Date
March 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80 bags

Product Description

CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1

Reason for Recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 36-252142, Exp. 7/16/2023.