Keystone Industries: Drug Recall

Recall #D-0046-2025 · 10/17/2024

Class II: Risk

Recall Details

Recall Number: D-0046-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Keystone Industries
Status: Ongoing
Date Initiated: 10/17/2024
Location: Gibbstown, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 787 pumps

Reason for Recall

Subpotent 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

Distribution Pattern

Nationwide within the United States

Other Recalls by Keystone Industries

Class II: Risk 11/14/2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II: Risk 11/14/2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II: Risk 11/14/2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II: Risk 11/14/2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II: Risk 11/14/2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

View all recalls by Keystone Industries →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.