dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharma...
FDA Recall #D-1138-2023 — Class II — August 17, 2023
Product Description
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 for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
703 bags.
Distribution
Nationwide in the USA
Code Information
Lot# 36-260048, Exp 9/13/2023; 36-262174, Exp 9/15/2023; 36-262523, Exp 9/19/2023. ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated