FDA Drug Class II — Moderate

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine 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. NDC: 51552-1539-1

Hazard

Microbial contamination of non-sterile product.

Products

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium
Brand
Fagron, Inc
UPC
Lot, expiry: 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, 2/4/2021; 19I03-U02-002020, 2/4/2021; 19I03-U03-002021, 12/17/2020

Units Affected

11,912 kits