New & Improved Blue Gel Anesthetic recalled over manufacturing violations

Recall date

February 9, 2023

Source

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

Official notice title

HTO Nevada, Inc. recalls New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distribu…

Recall number

D-0270-2023

FDA classification

Class II

Brand / firm

HTO Nevada, Inc.

Sold / distributed

Nationwide in the USA and Canada.

Why it was recalled

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

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

What was recalled

New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingredients -Lidocaine HCL (5%), Tetracaine HCL (1%) and epinephrine (0.1%).