Keystone Industries recalls Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Recalled December 25, 2024 · FDA recall D-0142-2025 · Keystone Industries
Hazard
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. · FDA Class II
Sold at
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Description
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.
Product
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Manufacturer(s)
Keystone Industries
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →