Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container...
FDA Recall #D-0444-2022 — Class II — December 6, 2021
Product Description
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
Reason for Recall
CGMP Deviations
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
231 bottles
Distribution
nationwide
Code Information
07-2021-02@7 12-29-2021, 07-2021-23@4 01-19-2022, 08-2021-11@7 02-07-2022, 08-2021-23@8 02-19-2022 & 09-2021-24@10 03-23-2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated