Quala topical anesthetic gel recalled for incomplete bottle seals
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 7 products — see all of them.
Details
- Units affected
- 150 units
- Illnesses reported
- None reported
- Manufactured in
- 480 S Democrat Rd, Gibbstown, NJ, United States
- Classification
- Class II
- Recall number
- D-0601-2026
In the FDA's words
- 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. Defective container:may contain bottles with incomplete seals BNZ-001921, EXP 04/15/2029 Distribution: Nationwide in the USA Affected quantity: 150 units
- Hazard
- Defective container:may contain bottles with incomplete seals
7 products in this recall
Pearson, Quala and more benzocaine gels recalled for incomplete seals
Keystone Industries is recalling 7 topical anesthetic gels containing 20% benzocaine, sold as Pearson Quality, Quala, DHP, Burkhart, Dental City, PureLife, and safco SensiCaine-Ultra. The recall is due to a container defect: some bottles may have incomplete seals. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 913…D-0600-2026 · 900 units
- 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.,… (this page)D-0601-2026 · 150 units
- DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Suga…D-0602-2026 · 150 units
- Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 4…D-0603-2026 · 150 units
- Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69…D-0604-2026 · 450 units
- PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson,…D-0605-2026 · 450 units
- safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove,…D-0606-2026 · 150 units