Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1.

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 # 37-894305, Exp 04/29/2023; 37-896153, Exp 05/06/2023; 37-897073, Exp 05/11/2023; 37-897925, 37-897941, Exp 05/13/2023; 37-899607, 37-899608, Exp 05/20/2023; 37-900320, Exp 05/22/2023

Distribution pattern: Nationwide in the USA.