Keystone Industries: Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.

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.

Details from the source

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. Lot/code info: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-29119

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.