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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Dermoplast First Aid Antibacterial Spray Recalled for Subpotency

Agency Publication Date: February 17, 2023
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Summary

Advantice Health, LLC is recalling 16,152 cans of Dermoplast First Aid Antibacterial Spray (benzethonium chloride and benzocaine). Stability testing revealed that one of the two active ingredients in the spray is less potent than required. This recall involves the 2.75 oz spray cans distributed nationwide through retailers, distributors, and internet sales. No injuries or adverse events have been reported to date.

Risk

The subpotency means the medication may not be as effective as intended in preventing infection or providing pain relief. Using a product with lower-than-labeled strength could lead to inadequate treatment of minor cuts, scrapes, or burns.

What You Should Do

  1. This recall affects 2.75 oz cans of Dermoplast First Aid Antibacterial Spray (benzethonium chloride 0.2% and benzocaine 20%) labeled with NDC 16864-670-01 and lot number 22336A.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dermoplast FIRST AID ANTIBACTERIAL SPRAY (2.75 oz)
Variants: Benzethonium chloride 0.2% (Antiseptic), Benzocaine 20% (Analgesic), Topical spray
Lot Numbers:
22336A
NDC:
16864-670-01

Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91581
Status: Resolved
Manufacturer: Advantice Health, Llc
Sold By: internet; distributors; retailers
Manufactured In: United States
Units Affected: 16,152 cans/673 cases
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.