FDA-Drug2023-02-22Class II
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%).
HTO Nevada, Inc.
Hazard
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Sold states
Nationwide in the USA and Canada.
Affected count
4709 bottles
Manufactured in
6400 Rosewood St, N/A, Lake Oswego, OR, United States
Products
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%).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2023Don't want to check this manually?
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