Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.

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 # 37-894326, Exp 04/29/2023; 37-895212, Exp 05/04/2023; 37-896794, Exp 05/08/2023; 37-897286, Exp 05/12/2023; 37-899267, Exp 05/19/2023

Distribution pattern: Nationwide in the USA.