Edge Pharma, LLC recalls Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-M
Recalled February 2, 2022 · FDA recall D-0441-2022 · Edge Pharma
Hazard
CGMP Deviations · FDA Class II
Units
418 jars
Sold at
nationwide
Description
CGMP Deviations
Product
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →