The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0271-2023·Announced 2023-02-22

FDA Recalls Maximum Zone2 Topical Analgesic Due to Epinephrine Discoloration

HTO Nevada's Maximum Zone2 Topical Analgesic (1oz, Lot #795CP-0003, NDC 80069-012-01) is recalled nationwide in the USA and Canada due to discoloration of the epinephrine active ingredient caused by a manufacturing deviation.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of a pharmaceutical product. The documented discoloration of the epinephrine API represents a manufacturing quality defect. No illnesses or injuries have been reported. The product is for professional use only, but qualifies as a risk-of-harm item due to the potent nature of epinephrine.

Plain-English summary

HTO Nevada, Inc., is recalling 1,571 bottles of Maximum Zone2 Topical Analgesic (1oz bottles, NDC 80069-012-01, Lot #795CP-0003, expiration 07/2024) distributed nationwide in the USA and Canada. The product is distributed by DERMAL SOURCE in Portland, Oregon.

The recall is due to discoloration of the epinephrine active pharmaceutical ingredient (API), identified as a current Good Manufacturing Practice (cGMP) deviation in the repackager's raw material. Epinephrine is a critical component of this topical anesthetic formulation used during pain-sensitive procedures in professional settings.

The product is intended for licensed professionals only. No illnesses or injuries have been reported to date. Healthcare facilities and licensed professionals who have received this product should cease use of affected lots and contact DERMAL SOURCE at 1-866-568-3223 or visit www.dermalsource.com for instructions on return and replacement.

The recalled product

Product
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine…
Manufacturer
HTO Nevada, Inc.
Category
Drug — Topical Analgesic / Local Anesthetic
Hazard
Affected units
1,571

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 (2)

  • Lot #: 795CP-0003
  • Exp 07/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by HTO Nevada, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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