Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallo...
FDA Recall #D-0439-2022 — Class II — December 6, 2021
Product Description
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
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
353 jars
Distribution
nationwide
Code Information
07-2021-20@7 01-16-2022, 08-2021-11@6 02-07-2022, 08-2021-31@11 02-01-2022, 09-2021-14@11 02-01-2022, 09-2021-21@6 02-01-2022 & 10-2021-12@4 04-10-2022.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated