vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture...
FDA Recall #D-0967-2023 — Class II — July 14, 2023
Product Description
vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
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
6,772 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-238968, 36-238985, 36-238992, 36-238998, Exp. 7/10/2023; 36-240784, 36-240785, 36-240786, 36-240787, Exp. 7/17/2023; 36-240840, 36-240842, Exp. 7/18/2023; 36-243157, Exp. 7/27/2023; 36-243953, Exp. 7/31/2023; 36-251050, 36-251051, 36-251059, Exp. 8/24/2023; 36-252196, 36-252197, 36-252200, Exp. 8/31/2023; 36-254418, Exp. 9/5/2023; 36-256916, Exp. 9/13/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated