FDA Drug recall D-0141-2025
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply,…
- FDA Drug
- Class II
- terminated
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply,… by Keystone Industries, citing CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Pro….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0141-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-11-14 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Keystone Industries |
| Distribution | US |
Product
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3.
Reason
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Identifiers
| ndc | 50227-1002-3 |
|---|---|
| code_info | Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-27119 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-06-24 · Keystone Industries - DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, In…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
All Keystone Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0141-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.