Drug product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
D-0440-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160,848 Tubes
- Official record key
drug-enforcement:D-0440-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0032, B0047, B0048, B0055, B0056, Exp Date: 07/31/2026; B0102, B0103, B0104, B0105, B0106, B0107, Exp Date: 09/30/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations