Drug product
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
D-0430-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 383,904 Tubes
- Official record key
drug-enforcement:D-0430-2025
Official wording
Reason: CGMP Deviations
Code information: Lot B0011, B0012, Exp Date: 05/31/2026; Lot B0070, B0074, Exp Date: 08/31/2026; Lot B0075, B0077, B0078, B0079, B0080, B0081, B0082, B0083, B0084, B0085, Exp Date: 09/30/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations