OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den
Summary
The FDA issued a Class II for OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol by Den-Mat Holdings, LLC. Reason: CGMP Deviations: products may not conform to the labeled specifications..
Details
Source
Drug Recall
External ID
D-0286-2024
Action Date
2024-02-07
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
Quantity Affected: 344 tubes
Reason for Recall
CGMP Deviations: products may not conform to the labeled specifications.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-16
Company
Lompoc, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 57 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Den-Mat Holdings, LLC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Den-Mat Holdings, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Den-Mat Holdings, LLC have FDA actions?
Den-Mat Holdings, LLC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0286-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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