FDA Drugs recall ·
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine… recall
- Recall number
- D-0146-2025
- Date
- (initiated November 14, 2024)
- Company / brand
- Keystone Industries
480 S Democrat Rd, Gibbstown, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419
Distribution
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0146-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.