Drug product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
D-0434-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216,720 Tubes
- Official record key
drug-enforcement:D-0434-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0013, Exp Date: 05/31/2026; Lot B0018, Exp Date: 06/30/2026; Lot B0053, B0054, Exp Date: 07/31/2026; Lot B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101, Exp Date: 09/30/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations