Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.

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 # 37-895694, 37-896050, Exp 05/05/2023; 37-898304, Exp 05/14/2023; 37-899234, Exp 05/19/2023; 37-901375, Exp 05/27/2023

Distribution pattern: Nationwide in the USA.