Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.

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 # 37-893850, Exp 04/28/2023; 37-894947, Exp 05/01/2023; 37-895695, Exp 05/05/2023; 37-896484, Exp 05/07/2023; 37-898314, Exp 05/14/2023; 37-898811, Exp 05/18/2023; 37-900616, Exp 05/25/2023

Distribution pattern: Nationwide in the USA.