Drug product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
D-0436-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 498,960 Tubes
- Official record key
drug-enforcement:D-0436-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0015, B0016, Exp Date: 05/31/2026; Lot B0020, B0021, B0022, Exp Date: 06/30/2026; Lot B0056, B0057, Exp Date: 07/31/2026; Lot B0108, B0109, B0110, Exp Date: 09/30/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations