vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture ...
FDA Recall #D-0970-2023 — Class II — July 14, 2023
Product Description
vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1
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
5,588 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-239526, Exp. 7/12/2023; 36-239993, Exp. 7/13/2023; 36-240796, Exp. 7/17/2023; 36-241982, Exp. 7/24/2023; 36-242696, Exp. 7/26/2023; 36-243161, Exp. 7/27/2023; 36-243954, Exp. 7/31/2023; 36-245534, Exp. 8/2/2023; 36-247885, Exp. 8/10/2023; 36-248977, 36-249137, Exp. 8/16/2023; 36-251052, Exp. 8/24/2023; 36-251705, 36-251706, Exp. 8/29/2023; 36-252190, Exp. 8/31/2023; 36-255490, 36-255492, 36-255494, Exp. 9/7/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.