Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV In...
FDA Recall #D-0425-2022 — Class II — December 6, 2021
Product Description
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
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
1795 bags
Distribution
nationwide
Code Information
09-2021-13@3 12/27/2021 & 09-2021-30@5 01/13/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated