HTO Nevada, Inc. recalls New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distribut
Recalled February 22, 2023 · FDA recall D-0270-2023 · HTO Nevada
Hazard
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. · FDA Class II
Units
4709 bottles
Sold at
Nationwide in the USA and Canada.
Description
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Product
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%).
Manufacturer(s)
HTO Nevada, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →