FDA-Drug2022-02-02Class II

PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01

Edge Pharma, LLC
Hazard

Lack of Assurance of Sterility

Sold states
nationwide
Affected count
3930 bags
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0418-2022

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