Home / Recalls / HTO Nevada, Inc. / D-0270-2023

D-0270-2023 Class II Terminated

Recalled by HTO Nevada, Inc. — Lake Oswego, OR

Recall Details

Product Type: Drugs
Report Date: February 22, 2023
Initiation Date: February 9, 2023
Termination Date: November 17, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4709 bottles

Product Description

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%).

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Canada.

Code Information

Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.