RecallRadar

FDA Drug recall D-0270-2023

New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source…

On 2023-02-22 the FDA classified a Class II recall of New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source… by Hto Nevada, citing cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0270-2023
ClassificationClass II
Statusterminated
Initiated2023-02-09
Published2023-02-22
Last updated2026-09-13 11:52 UTC
CompanyHto Nevada
DistributionUS

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

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0270-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.