Status
Ongoing
Drug Enforcement D-0286-2024
CGMP Deviations: products may not conform to the labeled specifications.
Classification
Class II
Report Date
February 7, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- 344 tubes
- Reason for recall
- CGMP Deviations: products may not conform to the labeled specifications.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Den-Mat Holdings, LLC
- Address
-
1017 W Central Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0286-2024
- Event ID
- 93831
- Recall initiation date
- January 16, 2024
- Center classification date
- January 31, 2024
- Code info
- Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
- More code info
- —