FDA-Drug2022-02-02Class II

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

Edge Pharma, LLC
Hazard

Lack of Assurance of Sterility

Sold states
nationwide
Affected count
1795 bags
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2022

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