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Recall Observatory FDA recall evidence

Drug product

Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.

D-0601-2026

May 21, 2026

Class II

Product summary

Firm
Keystone Industries
Event
Event 99076
Status
Ongoing
Classification
Class II
Quantity
150 units
Official record key
drug-enforcement:D-0601-2026

Official wording

Reason: Defective container:may contain bottles with incomplete seals

Code information: BNZ-001921, EXP 04/15/2029

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container:may contain bottles with incomplete seals