Drug & medication recalls Moderate risk

OralProCare medicated lip treatment recalled over manufacturing violations

Recall date
January 16, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Den-Mat Holdings, LLC recalls OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: De…
Recall number
D-0286-2024
FDA classification
Class II
Brand / firm
Den-Mat Holdings, LLC
Sold / distributed
Nationwide in the US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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