FDA recall D-0433-2025
KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
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-0433-2025