US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 6, 2021 (5 years ago)

Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

What was recalled

Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03

Recalling firm
Edge Pharma, LLC
NDC code
05446-1045-03
Origin
VT, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0444-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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