FDA Recall D-0286-2024
Den-Mat Holdings, LLC · Lompoc, CA
Class II Ongoing 849 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Recall record
- Recall number
D-0286-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2024-01-16
- Classified by FDA Center
- 2024-01-31
- FDA published
- 2024-02-07
- Recalling firm
- Den-Mat Holdings, LLC
- Firm location
- Lompoc, CA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.