FDA Drug Moderate Class II Ongoing

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.

Reported: February 7, 2024 Initiated: January 16, 2024 #D-0287-2024

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.

Reason for Recall

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

Details

Recalling Firm: Den-Mat Holdings, LLC
Units Affected: 10,103 units
Distribution: Nationwide in the US
Location: Lompoc, CA

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Den-Mat Holdings, LLC. Units affected: 10,103 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0287-2024.

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