FDA recall D-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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2023-02-02

Report date

2023-03-01

Termination date

2023-10-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cedar Knolls, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0329-2023