Skip to main content
MedicineWatch US
Explore records
Trends
Coverage
About
Methodology
Report an issue
Privacy
Class II Recall
Central Admixture Pharmacy Services, Inc.
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
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification
Class II
Status
Terminated
Lot
Lot # 37-895647, Exp 05/05/2023; 37-898310, Exp 05/14/2023; 37-899622, Exp 05/20/2023; 37-900951, Exp 05/26/2023
Date
2023-05-31
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.