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Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufacture...

FDA Recall #D-0139-2025 — Class II — November 14, 2024

Recall #D-0139-2025 Date: November 14, 2024 Classification: Class II Status: Completed

Product Description

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.

Reason for Recall

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.

Recalling Firm

Keystone Industries — Gibbstown, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

Code Information

Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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