FDARecalled Dec 25, 2024 · #D-0146-2025
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 ...
Hazard
Class II — temporary health risk
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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. Classification: Class II Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Keystone Industries
- Model numbers
- BNZ-001646
- UPCs
- —