Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.

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 # 37-894310, Exp 04/29/2023; 37-895259, Exp 05/04/2023; 37-898303, Exp 05/14/2023; 37-901367, Exp 05/27/2023

Distribution pattern: Nationwide in the USA.