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FDADecember 6, 2021drug

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 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

70109202208801232022105020120221005446040810

Recall history

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

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