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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91581

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 02, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Advantice Health, Llc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0329-2023
Recall number
D-0329-2023
Initiated
February 02, 2023
Classification
Class III
Status
Terminated
Recalling firm
Advantice Health, Llc
Quantity
16,152 cans/673 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.

Code information

Lot # 22336A

Distribution pattern

Product was distributed via the internet, distributors and retailers nationwide.