CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volu...
FDA Recall #D-1034-2023 — Class II — July 14, 2023
Product Description
CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
148 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-253954, Exp. 7/20/2023; 36-256032, Exp. 7/28/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated