Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppe...
FDA Recall #D-0440-2022 — Class II — December 6, 2021
Product Description
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
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
221 jars
Distribution
nationwide
Code Information
08-2021-16@12 02-01-2022 09/21/21 - 10/19/21 09-2021-13@8 02-01-2022 11/04/21 - 11/17/21 09-2021-29@8 03-01-2022 10/18/21 - 11/11/21 10-2021-26@7 04-24-2022 11/17/21 - 12/01/21
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated