FDA-Drug2022-02-02Class II

Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10

Edge Pharma, LLC
Hazard

Lack of Assurance of Sterility

Sold states
nationwide
Affected count
6535 vials
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2022

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