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Recall Observatory FDA recall evidence

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

November 14, 2024

Class II

Product summary

Firm
Keystone Industries
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

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations