LT Topical Cream 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 LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC…

Recall number

D-0436-2022

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

LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01