FDAClass IIFebruary 20, 2019

LET Gel 4% recall: Labeling Error

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…

Why was LET Gel 4% 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.

Product
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…
Recalling firm
US Compounding Inc
Quantity
1931 syringes
Distribution
Nationwide in the USA.
Recall date
February 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls