FDA recall D-0141-2025

Keystone Industries · Class II · drug

Product

Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3.

Reason for recall

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.

Distribution

Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

Key facts

Status
Terminated
Initiation date
2024-11-14
Report date
2024-12-25
Termination date
2026-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gibbstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2025