FDA recall D-0286-2024

Product

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.

Reason for recall

CGMP Deviations: products may not conform to the labeled specifications.

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2024-01-16

Report date

2024-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lompoc, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2024