WhichRecall
Class IIReported 2024-12-25

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

Recalled by Keystone Industries

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

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Product was to be rejected but was inadvertently released and shipped to customers.

Recall Number
D-0146-2025
Classification
Class II
Status
Completed
Category
drug
Initiated
2024-11-14
Reported
2024-12-25
Distribution
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Code Info
Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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