Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melvi
Summary
The FDA issued a Class II for Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 by Keystone Industries. Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bot.
Details
Source
Drug Recall
External ID
D-0148-2025
Action Date
2024-12-25
Status
Terminated
Category
drug
Product Description
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,
Lot/Code Info: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-14
Company
Gibbstown, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 75 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Keystone Industries) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Keystone Industries have FDA actions?
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0148-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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