Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.
Recall Number: D-0662-2023
Firm: Central Admixture Pharmacy Services, Inc.
Classification: Class II
Status: Terminated
Report Date: 20230531
Initiation Date: 20230428
Termination Date: 20250622
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Product Description
Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.