FDA-Drug2022-02-02Class II
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Edge Pharma, LLC
Hazard
CGMP Deviations
Sold states
nationwide
Affected count
175 jars
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0442-2022Don't want to check this manually?
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