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Unrated Drug recall · FDA · Published November 16, 2018

CAO Group recalls SHEER DesenZ Desensitizing Treatment due to cGMP violations

CAO Group recalls SHEER DesenZ Desensitizing Treatment (Rx Only) due to cGMP violations during inspection. Products with specific UPC/NDC numbers and expiration dates are affected.

🇺🇸 FDA recall #D-0291-2019DrugCAO Group ›
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Recalling firmCAO Group, Inc.4628 W Skyhawk Dr · West Jordan, UT 84084-4501
✎ GovInfoNow plain-language explainer

What happened, in plain English

CAO Group is recalling SHEER DesenZ Desensitizing Treatment (Rx Only) because of cGMP violations found during a recent inspection. This means the product may not meet quality standards, but the recall does not specify immediate safety risks. Read more at govinfonow.com/recall/39425-cao-group-recalls-sheer-desenz-desensitizing-treatment-due-to-cgmp.

Source Summary by GovInfoNow · govinfonow.com/recall/39425-cao-group-recalls-sheer-desenz-desensitizing-treatment-due-to-cgmp · Updated October 5, 2026 · FDA enforcement record: FDA #D-0291-2019

Cite this page

“CAO Group recalls SHEER DesenZ Desensitizing Treatment due to cGMP violations.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39425-cao-group-recalls-sheer-desenz-desensitizing-treatment-due-to-cgmp. Based on FDA recall #D-0291-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0291-2019%22&limit=1).

Why it’s dangerous

The recall is due to cGMP (Current Good Manufacturing Practice) violations noted during a recent inspection. These violations indicate the product may not meet quality standards, but the record does not specify how this affects safety or health.

Who’s affected

People who own or use the recalled SHEER DesenZ Desensitizing Treatment (Rx Only) with the listed UPC/NDC numbers and expiration dates are affected. Those with the specific lot numbers and expiration dates are at risk of receiving a product that does not meet quality standards.

How to tell if you have this one

Check for the product name 'SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film'. Look for the UPC 8 72320 00072 1 or NDC 1406000304 with lot numbers 170626 (expiring 6/26/2019) or 180131 (expiring 1/31/2020).

  • Brand
    CAO Group
  • Product
    SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive
  • Category
    Drug
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide in the US
Recall numberProduct, codes & lotsQuantity
D-0290-2019fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105; Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020115 kits
D-0291-2019SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304; Lot # 170626, EXP 6/26/2019; and 180131, EXP 01/31/202071 cartons
D-0292-2019BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084; Lots #: a) 110216, EXP 11/02/18; 170524, EXP 5/24/2019; 171116, EXP 11/16/2019; 180319, EXP 3/19/2020; b)110216, EXP 11/02/2018; 170323, EXP 3/23/2019; 180109, EXP 1/09/2020803 units (400 kit and 403 30 ml bottles)
D-0293-2019FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003; Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.602 cartons
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, UPC, NDC, lot numbers, and expiration dates to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Nov 16, 201812. FDA classified it Class II: Dec 11, 201823. Published in FDA’s Enforcement Report: Dec 19, 201834. FDA terminated the recall: Feb 27, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0291-2019 (November 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0291-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA