Vancomycin HCl in 0 recalled over sterility concerns

Recall date

December 6, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Edge Pharma, LLC recalls Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Fre…

Recall number

D-0427-2022

FDA classification

Class II

Brand / firm

Edge Pharma, LLC

Sold / distributed

nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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