vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharma...
FDA Recall #D-0950-2023 — Class II — July 14, 2023
Product Description
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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
4824 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-245562, Exp. 8/2/2023; 36-254425, Exp. 9/5/2023; 36-255129, Exp. 9/6/2023; 36-238965, Exp. 7/10/2023; 36-256041, Exp. 9/11/2023; 36-241129, 36-241130, Exp. 7/19/2023; 36-241438, Exp. 7/20/2023; 36-242703, Exp. 7/26/2023; 36-243163, 36-243164, Exp. 7/27/2023; 36-251724, 36-251727, Exp. 8/29/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated