FDARecalled Dec 25, 2024 · #D-0143-2025
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
Hazard
Class II — temporary health risk
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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. Classification: Class II Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Product details
- Product
- Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
- Type
- Drugs
- Manufacturer
- Keystone Industries
- Model numbers
- BNZ-001646
- UPCs
- —