Recall D-0146-2025
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
Recall D-0146-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0146-2025 |
| Event ID | 95854 |
| Distribution | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. |
| Recall Reason | 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. |
| Drug Classification | Class II |
| Drug Code Info | 20241225 |
| Recall Initiation Date | 20241114 |
| Report Date | 20241225 |
| Classification Date | 20241213 |
| Address | 480 S Democrat Rd Gibbstown, NJ 08027-1239 United States |
| Recalling Firm | Keystone Industries |
| Initial Notification | |
| Similar To |