Drug product
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
D-0439-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150,768 Tubes
- Official record key
drug-enforcement:D-0439-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0004, Exp Date: 05/31/2026; B0060, Exp Date: 07/31/2026; Lot B0067, B0071, B0072, Exp Date: 08/31/2026; Lot B0107, B0108, Exp Date: 09/30/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations