Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.

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 # 37-893846, Exp 04/28/2023; 37-895704, Exp 05/05/2023; 37-897079, Exp 05/11/2023; 37-897927, Exp 05/13/2023; 37-898814, Exp 05/18/2023; 37-900617, Exp 05/25/2023

Distribution pattern: Nationwide in the USA.