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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