Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.

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 # 37-894299, Exp 04/29/2023; 37-897051, Exp 05/11/2023; 37-897368, Exp 05/12/2023; 37-898794, Exp 05/18/2023; 37-899614, Exp 05/20/2023; 37-900608, Exp 05/25/2023

Distribution pattern: Nationwide in the USA.