FDA Drug recall D-0147-2025
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada
- FDA Drug
- Class II
- terminated
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada 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-0147-2025 |
| 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
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
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
| code_info | Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-35119 |
|---|
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-0147-2025%22
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