Drug 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.
D-0286-2024
Product summary
- Event
- Event 93831
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 344 tubes
- Official record key
drug-enforcement:D-0286-2024
Official wording
Reason: CGMP Deviations: products may not conform to the labeled specifications.
Code information: Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations