Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, P
Summary
The FDA issued a Class II for Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive pro by HTO Nevada, Inc.. Reason: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API..
Details
Source
Drug Recall
External ID
D-0271-2023
Action Date
2023-02-22
Status
Terminated
Category
drug
Product Description
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 HCL (5%), Epinephrine (0.01%).
Lot/Code Info: Lot #: 795CP-0003, Exp 07/2024.
Quantity Affected: 1,571 bottles
Reason for Recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Distribution
Nationwide in the USA and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-09
Company
Lake Oswego, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
HTO Nevada, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HTO Nevada, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HTO Nevada, Inc. have FDA actions?
HTO Nevada, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0271-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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