Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.

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 # 37-893802, Exp 04/28/2023; 37-894943, Exp 05/01/2023; 37-896487, Exp 05/07/2023; 37-898248, Exp 05/14/2023; 37-899171, Exp 05/19/2023

Distribution pattern: Nationwide in the USA.