Fagron, Inc recalls LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4
Recalled December 11, 2019 · FDA recall D-0533-2020 · Fagron
Hazard
Microbial contamination of non-sterile product. · FDA Class II
Units
11,912 kits
Sold at
Nationwide
Description
Microbial contamination of non-sterile product.
Product
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
Manufacturer(s)
Fagron, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →