Product: 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 for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: 20230428
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated