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.

Recall Number: D-0659-2023

Firm: Central Admixture Pharmacy Services, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230531

Initiation Date: 20230428

Termination Date: 20250622

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

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.