FDA recall D-0440-2025
KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
Reason for recall
CGMP Deviations
Distribution
DE and NC
Key facts
- Status
- Terminated
- Initiation date
- 2025-04-24
- Report date
- 2025-05-28
- Termination date
- 2026-02-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Ta. Kadi, District Mehsana, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2025