FDAHealthNovember 14, 2024
Keystone Industries — Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2024
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
What's affected?
- Product
- Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
- Brand
- Keystone Industries
- Lot code
- No
Additional details
Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-35119
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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