Dermoplast FIRST AID ANTIBACTERIAL SPRAY — Class III drug recall D-0329-2023
Terminated recall by Advantice Health, Llc, reported 2023-03-01, distributed nationwide. Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
| Recall number | D-0329-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advantice Health, Llc, Cedar Knolls, NJ, United States |
| Recall initiated | 2023-02-02 |
| Classified | 2023-02-17 |
| Reported by FDA | 2023-03-01 |
| Terminated | 2023-10-31 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 16864-0670, 16864-0670-01 |
| Lot numbers | 22336A |
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
Reason for recall
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0329-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.