Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.

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 # 37-894304, Exp 04/29/2023; 37-894946, Exp 05/01/2023; 37-896482, Exp 05/07/2023; 37-897933, Exp 05/13/2023; 37-900461, Exp 05/22/2023

Distribution pattern: Nationwide in the USA.