Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Denta
Summary
The FDA issued a Class II for Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavo by Keystone Industries. Reason: Defective container:may contain bottles with incomplete seals.
Details
Source
Drug Recall
External ID
D-0601-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: BNZ-001921, EXP 04/15/2029
Quantity Affected: 150 units
Reason for Recall
Defective container:may contain bottles with incomplete seals
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-21
Company
Gibbstown, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Keystone Industries) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Keystone Industries have FDA actions?
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0601-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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