Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Inj...
FDA Recall #D-0426-2022 — Class II — December 6, 2021
Product Description
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1825 bags
Distribution
nationwide
Code Information
08-2021-26@4 12/08/2021 & 09-2021-21@3 01/04/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated