← FDA ENFORCEMENT
D-0387-2026Class II

HTO Nevada Inc. dba Kirkman

Recalling firm
HTO Nevada Inc. dba Kirkman
Product type
Drug
Status
Ongoing
Report date
2026-03-11
Distribution
Nationwide within the U.S
Firm state
OR
Product quantity
243 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Stability Data Does Not Support Expiry Date.

Product description

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Code / lot info

Lot #: 795CP-0005, Exp. Date 06/30/2026

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.