Recalls / Class III
Class IIID-0329-2023
Product
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
- Brand name
- Dermoplast First Aid
- Generic name
- Benzethonium Chloride And Benzocaine
- Active ingredients
- Benzethonium Chloride, Benzocaine
- Route
- Topical
- NDC
- 16864-670
- FDA application
- M003
- Affected lot / code info
- Lot # 22336A
Why it was recalled
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Recalling firm
- Firm
- Advantice Health, Llc
- Manufacturer
- Advantice Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 E Frederick Pl Ste 100, N/A, Cedar Knolls, New Jersey 07927-1815
Distribution
- Quantity
- 16,152 cans/673 cases
- Distribution pattern
- Product was distributed via the internet, distributors and retailers nationwide.
Timeline
- Recall initiated
- 2023-02-02
- FDA classified
- 2023-02-17
- Posted by FDA
- 2023-03-01
- Terminated
- 2023-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0329-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.