FDA-Drug2026-06-24Class IIPACKAGING DEFECT
Quala topical anesthetic gel recalled for incomplete bottle seals
What this means
Quala Dental Products topical anesthetic gel (20% benzocaine, strawberry flavor, 1 oz bottles) may have incomplete seals on some bottles. This could allow the product to leak or become contaminated. The recall affects 150 units distributed nationwide.
- Check your Quala topical anesthetic gel bottles for lot BNZ-001921 with expiration date 04/15/2029.
- Do not use bottles with incomplete or damaged seals.
- Contact NDC Inc. at 407 Sanford Road, Le Vergne, TN 37086 for a replacement or refund.
The agency's original wording
Hazard
Defective container:may contain bottles with incomplete seals
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
150 units
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0601-2026Want us to check the next one for you?
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