← FDA ENFORCEMENT
D-0286-2024Class 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
344 tubes
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

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.

Code / lot info

Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.

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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.