FDA-Drug2022-02-02Class II

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

Edge Pharma, LLC
Hazard

Lack of Assurance of Sterility

Sold states
nationwide
Affected count
749 bags
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2022

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