Drug Enforcement D-0046-2025

Subpotent Drug

Status

Ongoing

Classification

Class II

Report Date

November 20, 2024

Termination Date

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Product Information

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
Product quantity
787 pumps
Reason for recall
Subpotent Drug
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Keystone Industries
Address
480 S Democrat Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0046-2025
Event ID
95647
Recall initiation date
October 17, 2024
Center classification date
November 14, 2024
Code info
Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
More code info
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