FDAClass IIFebruary 7, 2024

OralProCare medicated lip treatment recall: CGMP Deviations

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…

Why was OralProCare medicated lip treatment recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Den-Mat Holdings, LLC
Quantity
344 tubes
Distribution
Nationwide in the US
Recall date
February 7, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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