Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.

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 # 37-893790, Exp 04/28/2023; 37-896488, Exp 05/07/2023; 37-898250, Exp 05/14/2023; 37-899235, Exp 05/19/2023; 37-900609, Exp 05/25/2023

Distribution pattern: Nationwide in the USA.