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Recall Observatory FDA recall evidence

Drug 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

D-0146-2025

November 14, 2024

Class II

Product summary

Firm
Keystone Industries
Event
Event 95854
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0146-2025

Official wording

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.

Code information: Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419

Distribution pattern: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations

Field note

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