Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-02...
FDA Recall #D-0142-2025 — Class II — November 14, 2024
Product Description
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
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. 03-28119
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated