Class II
Completed
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
This recall has been completed (originally issued December 25, 2024).
- Company
- Keystone Industries
- Recall Initiated
- November 14, 2024
- Posted
- December 25, 2024
- Recall Number
- D-0148-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Gibbstown, NJ, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Lot / Code Info
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
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