Reported Feb 22, 2023 · Terminated
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE,…
HTO Nevada, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HTO Nevada, Inc. · 6400 Rosewood St · Lake Oswego, OR · 97035-5392
Is this the product you have?
Maximum Zone2 Topical Analgesic1oz bottlefor use during a pain sensitive procedure
- distributed byDERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223
- NDC code80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%)
- Lot codes and dates
Lot #: 795CP-0003Exp 07/2024
- Amount recalled
- 1,571 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new HTO Nevada, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.