drugs Class II Updated 2024-12-25

Keystone Industries recalls Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Fre

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-29119
View official government recall

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