Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.

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 # 37-893848, Exp 04/28/2023; 37-895681, Exp 05/05/2023; 37-899250, Exp 05/19/2023; 37-901355, Exp 05/27/2023

Distribution pattern: Nationwide in the USA.