Multiple Drug Recalls - Keystone Industries
Wed Dec 25 2024
1 of 5
Summary
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.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30. | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | |
| 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, | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only. | Safco Dental Supply Co. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | |
| Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30. | Dental Health Products, Inc. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | |
| Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409. | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. | ||
| Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3. | Patterson Dental | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. |