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FDADecember 6, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations

What to do

FDA enforcement status: Terminated

Brands named

edge pharmaedge

UPCs

05446079010

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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