D-0146-2025 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2024
- Initiation Date
- November 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
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 Pattern
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Code Information
Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419