Drug 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.
D-0139-2025
Product summary
- Event
- Event 95854
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0139-2025
Official wording
Reason: 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.
Code information: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119
Distribution pattern: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Derived failure modes
-
Manufacturing or process control
CGMP deviations