Recalls / Class II
Class IID-0146-2025
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
- Affected lot / code info
- Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419
Why it was 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.
Recalling firm
- Firm
- Keystone Industries
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 480 S Democrat Rd, Gibbstown, New Jersey 08027-1239
Distribution
- Distribution pattern
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Timeline
- Recall initiated
- 2024-11-14
- FDA classified
- 2024-12-13
- Posted by FDA
- 2024-12-25
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0146-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.