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OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacteria...

FDA Recall #D-0286-2024 — Class II — January 16, 2024

Recall #D-0286-2024 Date: January 16, 2024 Classification: Class II Status: Ongoing

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.

Reason for Recall

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

Recalling Firm

Den-Mat Holdings, LLC — Lompoc, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

344 tubes

Distribution

Nationwide in the US

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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