FDAFDA · Food and drugs·Recall number D-0147-2025
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Published December 25, 2024 · Recall initiated: November 14, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Keystone Industries
- Distributor
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Lot
- Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-35119
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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