vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Centr...
FDA Recall #D-0725-2023 — Class II — April 28, 2023
Product Description
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11338 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-883372, 37-883387, Exp 05/01/2023; 37-883790, Exp 05/02/2023; 37-884160, Exp 05/03/2023; 37-885320, 37-885321, 37-885324, Exp 05/08/2023; 37-885921, 37-885928, 37-885930, Exp 05/10/2023; 37-886270, Exp 05/11/2023; 37-887511, Exp 05/16/2023; 37-887666, 37-887670, Exp 05/17/2023; 37-888115, Exp 05/18/2023; 37-888841, Exp 05/22/2023; 37-889457, 37-889462, Exp 05/24/2023; 37-892638, 37-892641, 37-892648, Exp 06/06/2023; 37-892907, Exp 06/07/2023; 37-894437, 37-894443, 37-894450, Exp 06/13/2023; 37-895707, 37-895718, 37-895723, Exp 06/19/2023; 37-896532, 37-896535, Exp 06/21/2023; 37-898527, Exp 06/29/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated