← FDA ENFORCEMENT
D-0287-2024Class II

Den-Mat Holdings, LLC

Recalling firm
Den-Mat Holdings, LLC
Product type
Drug
Status
Ongoing
Report date
2024-02-07
Distribution
Nationwide in the US
Firm state
CA
Product quantity
10,103 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Code / lot info

Lot #: a) 2214500032, 2216700041, 2301900118, 2312600002, 2204800002, Exp. 02/05/2024; 2306100034, 2322000078, 2322200021 02/22/2024; 2318000026, Exp 02/24/2024; 2323000070, 2324400005, 2323300016, Exp 08/29/2025; 2324800079, Exp 08/30/2025; 2325800008, Exp 09/18/2025; 2328600011, 2328600032, 10/10/2025; 2324800123, Exp 10/11/2025; 2329700005, 2329700090, Exp 10/19/2025; 2330400003, Exp 10/25/2025; 2334100101, Exp 11/13/2025; 2335300019, 2335400038, Exp 12/19/2025. b) 2212200014, Exp 02/22/2024; 2323300017, Exp 08/29/2025; 2324800124, Exp 09/18/2025. c) 2211100001, Exp 02/24/2024; 2330500009, Exp 10/25/2025; 2333200014, Exp12/19/2025.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.