US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 14, 2023 (3 years ago)

CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Central Admixture Pharmacy Services, Inc.
Origin
AZ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1034-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.