Drug FDA Class II Terminated cGMP deviation
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Keystone Industries Published Dec 25, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 55/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Keystone Industries or your place of purchase with questions, and see the source record below for full details.
Reason for recall
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.
Hazards
Mixing vessel scratches · primary
Affected products (1)
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Code info: Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-35119
Affected areas
Nationwide
Timeline
- InitiatedNov 14, 2024
- PublishedDec 25, 2024
- TerminatedApr 23, 2026
- Recall number
- D-0147-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.