Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.

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 # 37-894325, Exp 04/29/2023; 37-895211, Exp 05/04/2023; 37-899265, Exp 05/19/2023

Distribution pattern: Nationwide in the USA.