Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.

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 # 37-893803, Exp 04/28/2023; 37-896483, Exp 05/07/2023; 37-897939, Exp 05/13/2023; 37-900952, Exp 05/26/2023

Distribution pattern: Nationwide in the USA.