Drug product
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3.
D-0141-2025
Product summary
- Event
- Event 95854
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0141-2025
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. 03-27119
Distribution pattern: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Derived failure modes
-
Manufacturing or process control
CGMP deviations