FDA-Drug2024-12-25Class II

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.

Keystone Industries
Hazard

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.

Sold states
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
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.

Official notice

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

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