Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx ...
FDA Recall #D-0653-2023 — Class II — April 28, 2023
Product Description
Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
338 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-893847, Exp 04/28/2023; 37-895646, Exp 05/05/2023; 37-897804, Exp 05/12/2023; 37-899236, Exp 05/19/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated