drugs Class II Updated 2024-12-25

Keystone Industries recalls Quala Dental Products, Topical Anesthetic Gel, Contains 20%

Recalled Product

Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com

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 No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419
View official government recall

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