D-0142-2025 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2024
- Initiation Date
- November 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
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