Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: Lot # 37-894300, Exp 04/29/2023; 37-896114, Exp 05/06/2023; 37-896417, Exp 05/07/2023; 37-897388, Exp 05/12/2023; 37-898798, Exp 05/18/2023; 37-899618, Exp 05/20/2023

Distribution pattern: Nationwide in the USA.