FDA-Drug2024-12-25Class II
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
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
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2025Don't want to check this manually?
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