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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Status
Terminated
Lot
Lot: 36-243946, 36-243947, 36-243948, 36-243949, Exp. 7/11/2023; 36-255120, Exp. 8/17/2023; 36-246829, 36-246831, 36-246832, Exp. 7/18/2023; 36-255961, Exp. 8/21/2023; 36-256896, Exp. 8/25/2023.
Date
2023-08-09
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.