Why it was recalled
CGMP Deviations: products may not conform to the labeled specifications.
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 numbers, UPCs & expiration codes
Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0286-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 16, 2024
- FDA report date
- Feb 7, 2024
- Quantity
- 344 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Den-Mat Holdings, LLC
Original FDA data
Every field from FDA enforcement report D-0286-2024, exactly as published.
Show all FDA fields
- City
- Lompoc
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 93831
- Address
- 1017 W Central Ave
- Code information
- Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
- Postal code
- 93436-2701
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0286-2024
- Classification
- Class II
- Recalling firm
- Den-Mat Holdings, LLC
- Product quantity
- 344 tubes
- Reason for recall
- CGMP Deviations: products may not conform to the labeled specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jan 16, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2024