Drug recall D-0142-2025

Class II Terminated reported Dec 25, 2024

Product

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.

Lots and codes

Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-28119

Recall details

Recalling firm
Keystone Industries, Gibbstown, NJ
Distribution
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Type
Voluntary: Firm initiated
Recall initiated
November 14, 2024
Terminated
April 23, 2026

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