ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by
Summary
The FDA issued a Class II for ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0. by PRITAM INTERNATIONAL PRIVATE LIMITED. Reason: CGMP Deviations..
Details
Source
Drug Recall
External ID
D-0068-2027
Action Date
2026-10-28
Status
Ongoing
Category
drug
Product Description
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Lot/Code Info: Lot # LWP250047850611D, Exp Date: 12/23/2027; Lot # LWP260052612201D, Exp Date: 04/30/2028.
Quantity Affected: 15,264 tubes
Reason for Recall
CGMP Deviations.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-10
Company
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 34 drug recalls issued in the same week, part of 76 drug-related FDA actions this month.
PRITAM INTERNATIONAL PRIVATE LIMITED has 17 FDA actions in our database, including 17 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 (PRITAM INTERNATIONAL 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 PRITAM INTERNATIONAL PRIVATE LIMITED have FDA actions?
PRITAM INTERNATIONAL PRIVATE LIMITED has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0068-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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