LET Topical Gel recalled over manufacturing violations

Recall date

December 6, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Edge Pharma, LLC recalls LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe fo…

Recall number

D-0437-2022

FDA classification

Class II

Brand / firm

Edge Pharma, LLC

Sold / distributed

nationwide

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01