FDA recall D-0270-2023

HTO Nevada, Inc. · Class II · drug

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%).

Reason for recall

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

Distribution

Nationwide in the USA and Canada.

Key facts

Status
Terminated
Initiation date
2023-02-09
Report date
2023-02-22
Termination date
2023-11-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Oswego, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2023