Den-Mat Holdings, LLC: Drug Recall

Recall #D-0287-2024 · 01/16/2024

Class II: Risk

Recall Details

Recall Number
D-0287-2024
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
10,103 units

Reason for Recall

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

Product Description

Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.

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.