PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: February 7, 2024 Initiated: January 16, 2024 #D-0286-2024

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.

Details

Recalling Firm
Den-Mat Holdings, LLC
Units Affected
344 tubes
Distribution
Nationwide in the US
Location
Lompoc, CA

Frequently Asked Questions

What product 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.. Recalled by Den-Mat Holdings, LLC. Units affected: 344 tubes.
Why was this product recalled?
CGMP Deviations: products may not conform to the labeled specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0286-2024.