Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analg
Summary
The FDA issued a Class III for Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid a by Advantice Health, Llc. Reason: Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing..
Details
Source
Drug Recall
External ID
D-0329-2023
Action Date
2023-03-01
Status
Terminated
Category
drug
Product Description
Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01
Lot/Code Info: Lot # 22336A
Quantity Affected: 16,152 cans/673 cases
Reason for Recall
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Distribution
Product was distributed via the internet, distributors and retailers nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-02
Company
Cedar Knolls, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 97 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Advantice Health, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advantice Health, Llc have FDA actions?
This is the only FDA action we have on record for Advantice Health, Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0329-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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