Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.

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 # 37-893789, Exp 04/28/2023; 37-894318, Exp 04/29/2023; 37-895648, Exp 05/05/2023; 37-897301, Exp 05/12/2023; 37-898815, Exp 05/18/2023

Distribution pattern: Nationwide in the USA.