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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

CAO Group, Inc.: Topical Anesthetics and Hemostat Gels Recalled for Manufacturing Violations

Agency Publication Date: December 11, 2018
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Summary

CAO Group, Inc. is recalling approximately 1,591 units of various dental products, including BeeGentle Topical Anesthetic, fas.TRACT and FastStat Hemostatic Gels, and SHEER DesenZ Desensitizing Treatment. This recall was initiated due to violations of Current Good Manufacturing Practice (cGMP) regulations discovered during a recent facility inspection. These manufacturing failures mean the company cannot guarantee the safety, purity, or potency of these medications. Consumers should immediately contact their healthcare provider or pharmacist for guidance regarding these products and return any unused portions to the place of purchase.

Risk

The manufacturing violations indicate that the facility failed to meet quality control standards required to ensure the products are safe and effective for use. While no specific injuries were reported, products manufactured under substandard conditions pose a risk of contamination or incorrect ingredient levels, which could lead to ineffective treatment or adverse reactions in patients.

What You Should Do

  1. Identify if you have any of the affected products by checking for these specific lot numbers: fas.TRACT (Lots 170831, 180704), SHEER DesenZ (Lots 170626, 180131), BeeGentle (Lots 110216, 170524, 171116, 180319, 170323, 180109), and FastStat (Lots 170626, 171214).
  2. Check the expiration dates on your packaging to see if they match the recalled ranges, which extend from November 2018 through July 2020.
  3. If you are a patient who has received treatment using these products, contact your healthcare provider or dentist for further guidance.
  4. Return any unused products to the dental office or pharmacy where they were obtained to receive a refund.
  5. Contact CAO Group, Inc. at 4628 West Skyhawk Drive, West Jordan, UT 84084 for further instructions regarding product returns.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse events.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit
Model:
NDC 14060-01105
Lot Numbers:
170831 (Exp 8/31/2019)
180704 (Exp 7/04/2020)
Product: SHEER DesenZ Desensitizing Treatment (Potassium Nitrate 12mg per film)
Model:
NDC 1406000304
UPC Codes:
872320000721
Lot Numbers:
170626 (Exp 6/26/2019)
180131 (Exp 01/31/2020)
Product: BeeGentle Honey Flavored Topical Anesthetic Introductory Kit (Benzocaine 20%)
Model:
NDC 1406000203
UPC Codes:
872320000745
Lot Numbers:
110216 (Exp 11/02/18)
170524 (Exp 5/24/2019)
171116 (Exp 11/16/2019)
180319 (Exp 3/19/2020)
Product: BeeGentle Honey Flavored Topical Anesthetic Bulk Kit 30mL (Benzocaine 20%)
Model:
NDC 1406000202
UPC Codes:
872320000769
Lot Numbers:
110216 (Exp 11/02/2018)
170323 (Exp 3/23/2019)
180109 (Exp 1/09/2020)
Product: FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%
Model:
NDC 1406001003
Lot Numbers:
170626 (Exp 6/26/2019)
171214 (Exp 12/14/2019)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81556
Status: Resolved
Manufacturer: CAO Group, Inc.
Sold By: Benco Dental; Dental clinics; Professional dental distributors
Manufactured In: United States, China
Units Affected: 4 products (115 kits; 71 cartons; 803 units (400 kit and 403 30 ml bottles); 602 cartons)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.