Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India,
Summary
The FDA issued a Class II for Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, N by KENIL HEALTHCARE PRIVATE LIMITED. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0440-2025
Action Date
2025-05-28
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot B0032, B0047, B0048, B0055, B0056, Exp Date: 07/31/2026; B0102, B0103, B0104, B0105, B0106, B0107, Exp Date: 09/30/2026
Quantity Affected: 160,848 Tubes
Reason for Recall
CGMP Deviations
Distribution
DE and NC
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-24
Company
Ta. Kadi, District Mehsana, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
KENIL HEALTHCARE PRIVATE LIMITED has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (KENIL HEALTHCARE PRIVATE LIMITED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does KENIL HEALTHCARE PRIVATE LIMITED have FDA actions?
KENIL HEALTHCARE PRIVATE LIMITED has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0440-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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