vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixtu...
FDA Recall #D-0955-2023 — Class II — July 14, 2023
Product Description
vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
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
15,304 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-254431, Exp. 9/5/2023; 36-255125, 36-255126, 36-255127, Exp. 9/6/2023; 36-248083 Exp. 8/10/2023; 36-238973, 36-238980, Exp. 7/10/2023; 36-239520, Exp. 7/12/2023; 36-240087, Exp. 7/13/2023; 36-248979, 36-248980, 36-248981, Exp. 8/16/2023; 36-240760, 36-240761, 36-240762, Exp. 7/17/2023; 36-240837, 36-240838, Exp. 7/18/2023; 36-241131, 36-241132, Exp. 7/19/2023; 36-241436, Exp. 7/20/2023; 36-251065, Exp. 8/24/2023; 36-241980, Exp. 7/24/2023; 36-242707, Exp. 7/26/2023; 36-243153, 36-243155, 36-243156, Exp. 7/27/2023; 36-252188, 36-252189, 36-252191, 36-252192, 36-252198, 36-252201, Exp. 8/31/2023; 36-243951, Exp. 7/31/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated