The Recall Desk
HighFDA (Drugs)·D-0270-2023·Announced 2023-02-22

New & Improved Blue Gel Anesthetic Recalled Nationwide for API Discoloration

HTO Nevada, Inc. is recalling 4,709 bottles of New & Improved Blue Gel Anesthetic nationwide due to discoloration of the epinephrine active pharmaceutical ingredient resulting from a cGMP deviation in the raw material supply.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a manufacturing defect affecting a critical medication (epinephrine-containing anesthetic). Although no illnesses or injuries have been reported, the discoloration of the API in this risk-of-harm product warrants a High severity rating per the rubric criterion for risk-of-harm products without yet-reported injury.

Plain-English summary

HTO Nevada, Inc. is recalling 4,709 bottles of New & Improved Blue Gel Anesthetic distributed nationwide in the USA and Canada. The product is a topical anesthetic containing lidocaine HCL (5%), tetracaine HCL (1%), and epinephrine (0.1%), intended for use by licensed professionals to reduce pain and swelling during pain-sensitive procedures.

The recall was initiated due to a current Good Manufacturing Practice (cGMP) deviation identified in a raw material supplied by the repackager. The specific defect is discoloration of the epinephrine active pharmaceutical ingredient (API) in affected batches. While no illnesses or injuries have been reported to date, the discoloration raises concerns about the integrity and potential efficacy of the active ingredient.

The affected lots are: Lot #796CP-0006 with expiration date 02/2024 and Lot #796CP-0007 with expiration date 03/2024 (NDC Code: 80069-008-01). The product was distributed by Dermal Source, Portland, OR. Customers in possession of the recalled lots should discontinue use immediately and contact Dermal Source at 1-888-568-3223 or visit www.dermalsource.com for further instructions.

The recalled product

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 Ingre
Manufacturer
HTO Nevada, Inc.
Category
Drug — Topical Anesthetic
Hazard
  • api-discoloration
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category