US Compounding Inc recalls LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compou…

Recall date

January 24, 2019

Source

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

Recall number

D-0482-2019

FDA classification

Class II

Brand / firm

US Compounding Inc

Sold / distributed

Nationwide in the USA.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.

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 Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.