Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1.

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 # 37-894309, 37-894321, Exp 04/29/2023; 37-896159, Exp 05/06/2023; 37-898510, Exp 05/15/2023; 37-900324, Exp 05/22/2023

Distribution pattern: Nationwide in the USA.