Drug product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
D-0435-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,500 Tubes
- Official record key
drug-enforcement:D-0435-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0027, B0031, Exp Date: 06/30/2026; Lot B0032, Exp Date: 07/31/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations