FDA-Drug2022-02-02Class II
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Edge Pharma, LLC
Hazard
Lack of Assurance of Sterility
Sold states
nationwide
Affected count
5335 syringes
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0417-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief