Drug product
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
D-0438-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 616,160 Tubes
- Official record key
drug-enforcement:D-0438-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0014, B0015, B0022, B0023, Exp Date: 05/31/2026; Lot B0024, B0025, B0026, B0027, B0033, B0034, B0035, B0039, B0040, B0041, B0045, Exp Date: 06/30/2026; Lot B0046, Exp Date: 07/31/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations