FDA recall D-0432-2025

KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug

Product

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03

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-0432-2025