LETS GEL KIT Convenience Pack recalled over sterility concerns

Recall date

October 31, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0533-2020

FDA classification

Class II

Brand / firm

Fagron, Inc

Sold / distributed

Nationwide

Why it was recalled

Microbial contamination of non-sterile product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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