Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injec...
FDA Recall #D-0427-2022 — Class II — December 6, 2021
Product Description
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
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
749 bags
Distribution
nationwide
Code Information
09-2021-09@6 12/23/2021 & 10-2021-13@5 01/27/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated