FDA Drug recall D-0145-2025
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distribute…
- FDA Drug
- Class II
- terminated
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distribute… 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-0145-2025 |
| 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
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.
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 | 67239-0219-1 |
|---|---|
| code_info | Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2025%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.