Reported Dec 11, 2019 · Terminated

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4…

Fagron, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fagron, Inc · 2400 Pilot Knob Rd · Saint Paul, MN · 55120-1118

Is this the product you have?

  • LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL)
  • ContainsLETS
  • Powders for GelLidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120
  • NDC51552-1539-1
Lot codes and dates
  • Lot
  • expiry

    65 of 65 codes

    • 18F25-U03-044296
    • 11/8/2019
    • 18F25-U04-044297
    • 11/8/2019
    • 18H22-U06-045284
    • 1/24/2020
    • 18I24-U05-045853
    • 11/8/2019
    • 18K06-U03-047041
    • 1/24/2020
    • 18K06-U04-047042
    • 1/24/2020
    • 18K27-U11-047460
    • 3/16/2020
    • 18K28-U10-047519
    • 3/16/2020
    • 19A06-U02-048182
    • 3/16/2020
    • 19A06-U03-048183
    • 3/16/2020
    • 19A16-U13-048363
    • 3/16/2020
    • 19A21-U02-048503
    • 3/16/2020
    • 19B10-U02-048787
    • 3/16/2020
    • 19B14-U05-048781
    • 3/16/2020
    • 19C05-U01-049199
    • 3/16/2020
    • 19C05-U02-049200
    • 3/16/2020
    • 19C11-U07-049451
    • 3/16/2020 19C25-U02-048758
    • 3/16/2020
    • 19D07-U01-049884
    • 3/16/2020
    • 19D07-U02-049885
    • 3/16/2020
    • 19E09-U01-050298
    • 3/16/2020
    • 19E23-U01-050763
    • 9/11/2020
    • 19F16-U12-000052
    • 9/11/2020
    • 19F16-U13-000053
    • 10/24/2020
    • 19G07-U01-000357
    • 10/24/2020
    • 19G07-U02-000358
    • 10/24/2020
    • 19G21-U01-000930
    • 10/24/2020
    • 19G21-U02-000931
    • 12/17/2020
    • 19H01-U01-001172
    • 12/17/2020
    • 19H01-U02-001174
    • 12/17/2020
    • 19I03-U01-002019
Amount recalled
11,912 kits

Where it was sold

  • Nationwide

Why it was recalled

Microbial contamination of non-sterile product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 6, 2020 · Data as of Sep 19, 7:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.