D-1018-2023 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
192

Product Description

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 36-253953, Exp. 7/20/2023; 36-255639, Exp. 7/24/2023