FDA DrugsClass II
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavo...
Published: June 24, 2026Recall ID: D-0601-2026Category: drugsCountry: US
Reason for Recall / Hazard
Defective container:may contain bottles with incomplete seals
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Gibbstown |
| State | NJ |
| Openfda › Nui › 1 | N0000185508 |
| Openfda › Nui › 2 | N0000175629 |
| Openfda › Nui › 3 | N0000184306 |
| Openfda › Nui › 4 | M0000728 |
| Openfda › Unii | U3RSY48JW5 |
| Openfda › Route | DENTAL |
| Openfda › Rxcui | 238910 |
| Openfda › Spl id | 4d3b1eba-bdaa-54fd-e063-6394a90a7807 |
| Openfda › Brand name | QUALA TOPICAL ANESTHETIC GEL |
| Openfda › Spl set id | 9f94b65d-47e3-9c6b-e053-2a95a90aa1f8 |
| Openfda › Package ndc | 43128-034-30 |
| Openfda › Product ndc | 43128-034 |
| Openfda › Generic name | BENZOCAINE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs | Allergens [CS] |
| Openfda › Pharm class pe › 1 | Increased Histamine Release [PE] |
| Openfda › Pharm class pe › 2 | Cell-mediated Immunity [PE] |
| Openfda › Substance name | BENZOCAINE |
| Openfda › Pharm class epc | Standardized Chemical Allergen [EPC] |
| Openfda › Manufacturer name | National Distribution & Contracting, Inc |
| Openfda › Application number | M022 |
| Openfda › Is original packager | true |
| Event id | 99076 |
| Address 1 | 480 S Democrat Rd |
| Code info | BNZ-001921, EXP 04/15/2029 |
| Postal code | 08027-1239 |
| Report date | 20260624 |
| Product type | Drugs |
| Product quantity | 150 units |
| Reason for recall | Defective container:may contain bottles with incomplete seals |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260618 |
Overview
- Recalling FirmKeystone Industries
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA