Drug product
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
D-0431-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 391,680 Tubes
- Official record key
drug-enforcement:D-0431-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0009, B0017, Exp Date: 05/31/2026; Lot B0018, B0019, B0036, B0037, B0038, Exp Date: 06/30/2026; Lot B0049, Exp Date: 07/31/2026; B0063, Exp Date: 08/31/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations