FDA-Drug2022-02-02Class II

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10

Edge Pharma, LLC
Hazard

CGMP Deviations

Sold states
nationwide
Affected count
221 jars
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2022

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