Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint fla
Summary
The FDA issued a Class II for Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, by Keystone Industries. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0046-2025
Action Date
2024-11-20
Status
Ongoing
Category
drug
Product Description
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
Lot/Code Info: Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
Quantity Affected: 787 pumps
Reason for Recall
Subpotent Drug
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-17
Company
Gibbstown, NJ
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 38 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 clearances.
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 (Keystone Industries) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Keystone Industries have FDA actions?
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0046-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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