Product: Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA  18106, NDC 71285-0101-1.
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