FDA recall D-0287-2024

Product

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.

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-0287-2024