Den-Mat Holdings, LLC: Drug Recall

Recall #D-0286-2024 · 01/16/2024

Class II: Risk

Recall Details

Recall Number
D-0286-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Den-Mat Holdings, LLC
Status
Ongoing
Date Initiated
01/16/2024
Location
Lompoc, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
344 tubes

Reason for Recall

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

Product Description

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.

Distribution Pattern

Nationwide in the US

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.