FDAHealthNovember 14, 2024
Keystone Industries — Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2024
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
What's affected?
- Product
- Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
- Lot code
- BNZ-001646
Additional details
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-28119
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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