Dermoplast First Aid Spray
FDA Recall NDC 16864-670
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dermoplast First Aid (NDC 16864-670). A significant event, classified as Class III, was initiated on Feb 02, 2023 by Advantice Health, Llc. The reported reason for this action was: "Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Feb 02, 2023
Mar 01, 2023
16,152 cans/673 cases
Recall Profile & Regulatory Data
Event ID
91581
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Advantice Health, Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed via the internet, distributors and retailers nationwide.
Termination Date
Oct 31, 2023
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
Batch or Lot Expiration Information
Lot# 22336A
Affected Packages Involved in this Recall
16864-670-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
