LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syrin...
FDA Recall #D-0482-2019 — Class II — January 24, 2019
Product Description
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.
Reason for Recall
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.
Recalling Firm
US Compounding Inc — Conway, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1931 syringes
Distribution
Nationwide in the USA.
Code Information
Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated