The Recall Desk

FDA (Drugs) recall action 95854

Keystone Industries recalled 12 products on 2024-12-25

The FDA (Drugs) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products
12
Announced
2024-12-25
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–12 of 12

  • HighFDA (Drugs)··2024-12-25

    Quala Dental Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-12-25

    Benzocaine Topical Anesthetic Recalled for Manufacturing Equipment Defect

    Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.

    Product
    GELATO TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-12-25

    FDA Recalls Benzo-Jel Topical Anesthetic Gel Due to Manufacturing Defect

    Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.

    Product
    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,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-12-25

    Dental City Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Dental City Topical Anesthetic Gel (Benzocaine 20%) is recalled because the product was released and distributed despite failing quality inspection. Scratches were found in the mixing vessel during routine inspection.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Process Deviation

    Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released to customers.

    Product
    SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL (BENZOCAINE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-12-25

    FDA Recalls Health-Tec Benzocaine Topical Anesthetic Due to Manufacturing Defect

    Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.

    Product
    HEALTH-TEC TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-12-25

    Benzocaine Topical Gel Recalled Due to Manufacturing Quality Defect

    Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.

    Product
    Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-12-25

    Patterson Dental Topical Anesthetic Recalled for Manufacturing Quality Defect

    Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.

    Product
    PATTERSON DENTAL TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-12-25

    Topical anesthetic gel recall due to manufacturing quality control deviation

    Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.

    Product
    Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
    Category
    Distribution
    0 states