FDARecalled Dec 25, 2024 · #D-0139-2025
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
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
- Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
- Type
- Drugs
- Manufacturer
- Keystone Industries
- Model numbers
- BNZ-001646
- UPCs
- —