vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture...
FDA Recall #D-0966-2023 — Class II — July 14, 2023
Product Description
vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6076-1
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
3,648 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-239524, Exp. 7/12/2023; 36-240843, Exp. 7/18/2023; 36-241437, Exp. 7/20/2023; 36-242698, Exp. 7/26/2023; 36-243152, Exp. 7/27/2023; 36-245567, Exp. 8/2/2023; 36-251063, Exp. 8/24/2023; 36-252193, Exp. 8/31/2023; 36-255122, 36-255123, 36-255124, Exp. 9/6/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated