Category Archives: microbial contamination

USA – FDA Alert: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

FDA

Fast Facts

  • FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products (see list below) manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin.
  • FDA is aware of at least 28 deaths and 8 illnesses in dogs that ate the recalled product.
  • This is an ongoing investigation. Case counts and the scope of this recall may expand as new information becomes available.
  • Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.
  • Pets experiencing aflatoxin poisoning may have symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage), and/or diarrhea. In severe cases, this toxicity can be fatal. In some cases, pets may suffer liver damage but not show any symptoms.
  • Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness.  The pet owner should remove the food and make sure no other animals have access to the recalled product.
  • FDA is asking veterinarians who suspect aflatoxin poisoning in their patients to report the cases through the Safety Reporting Portal or by calling their local FDA Consumer Complaint Coordinators. Pet owners can also report suspected cases to the FDA.

What is the Problem?

On December 30, 2020, Midwestern Pet Food, Inc. announced a recall of certain lots of Sportmix pet food products after FDA was alerted about reports of at least 28 dogs that have died and eight that have fallen ill after consuming the recalled Sportmix pet food. Multiple product samples were tested by the Missouri Department of Agriculture and found to contain very high levels of aflatoxin. Aflatoxin is a toxin produced by the mold Aspergillus flavus and at high levels it can cause illness and death in pets. The toxin can be present even if there is no visible mold.

FDA is issuing this advisory to notify the public about the potentially fatal levels of aflatoxin in pet food products that may still be on store shelves, online, or in pet owners’ homes.

FDA is conducting follow-up activities at the manufacturing facility.

This is a developing situation and the FDA will update this page with additional information as it becomes available.

What are the Symptoms of Aflatoxin Poisoning in Pets?

Pets are highly susceptible to aflatoxin poisoning because, unlike people, who eat a varied diet, pets generally eat the same food continuously over extended periods of time. If a pet’s food contains aflatoxin, the toxin could accumulate in the pet’s system as they continue to eat the same food.

Pets with aflatoxin poisoning may experience symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums or skin due to liver damage), and/or diarrhea. In some cases, this toxicity can cause long-term liver issues and/or death. Some pets suffer liver damage without showing any symptoms. Pet owners whose pets have been eating the recalled products should contact their veterinarians, especially if they are showing signs of illness.

There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, pet owners should always wash their hands after handling pet food.

What Products are Involved?

On December 30, 2020, Midwest Pet Food, Inc. announced a recall of nine total lots of Sportmix pet food products. FDA and the Missouri Department of Agriculture are working with the firm to determine whether any additional products may have been made with the same ingredients containing potentially fatal levels of aflatoxin. As new information becomes available, this product list may continue to expand.

The list of recalled dry pet food products announced by Midwestern Pet Food, Inc. on December 30, 2020 is:

  • Sportmix Energy Plus, 50 lb. bag
    • Exp 03/02/22/05/L2
    • Exp 03/02/22/05/L3
    • Exp 03/03/22/05/L2
  • Sportmix Energy Plus, 44 lb. bag
    • Exp 03/02/22/05/L3
    • Sportmix Premium High Energy, 50 lb. bag
    • Exp 03/03/22/05/L3
  • Sportmix Premium High Energy, 44 lb. bag
    • Exp 03/03/22/05/L3
    • Sportmix Original Cat, 31 lb. bag
    • Exp 03/03/22/05/L3
  • Sportmix Original Cat, 15 lb. bag
    • Exp 03/03/22/05/L2
    • Exp 03/03/22/05/L3

Lot code information may be found on the back of bag and will appear in a three-line code, with the top line in format “EXP 03/03/22/05/L#/B###/HH:MM”

Example product label demonstrating location and format of lot code information.

The affected products were distributed to online retailers and stores nationwide within the United States.

What Do Retailers Need to Do?

Don’t sell or donate the affected pet food products. Contact the manufacturer for further instructions. The FDA also encourages retailers to contact consumers who have purchased recalled products, if they have the means to do so (such as through shopper’s card records or point-of-sale signs).

What Do Pet Owners Need to Do?

If your pet has symptoms of aflatoxin poisoning, contact a veterinarian immediately. Even pets without symptoms may have suffered liver damage, so you may want to contact your veterinarian if your dog has eaten any of the recalled products. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.

Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly.

There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, pet owners should always wash their hands after handling any pet food.

You can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

What Do Veterinarians Need to Do?

The FDA urges veterinarians treating aflatoxin poisoning to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostic testing. You can submit these reports electronically through the FDA Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and parties involved in the investigation. The agency will update this page as more information becomes available. 

Additional Information

RASFF Alerts – Aflatoxin – Dried Figs – Organic Peanut Kernels – Roasted and Salted Watermelon Seeds

RASFF

aflatoxins (B1 = 81 µg/kg – ppb) in dried figs from Spain in Spain

RASFF

aflatoxins (B1 = 54; Tot. = 64 µg/kg – ppb) in organic peanut kernels from Egypt in the Netherlands

RASFF

aflatoxins (B1 = 13.7 mg/kg – ppm) and ochratoxin A (11.4 mg/kg – ppm) in roasted and salted watermelon seeds from Turkey in Germany

RASFF

aflatoxins (B1 = 36; Tot. = 90 µg/kg – ppb) in organic dried figs from Turkey in the Netherlands

RASFF

aflatoxins (B1 = 53; Tot. = 55 µg/kg – ppb) in dried figs from Turkey in France

RASFF

aflatoxins (B1 = 17; Tot. = 18 µg/kg – ppb) in dried figs from Turkey in France

RASFF

aflatoxins (B1 = 17; Tot. = 22 µg/kg – ppb) in dried figs from Turkey

RASFF

aflatoxins (B1 = 48; Tot. = 109 µg/kg – ppb) in dried figs from Turkey in France

RASFF Alerts – E.coli – Chilled Burrata – Chilled Mussels

European Food Alerts

RASFF

high count of Escherichia coli (730000 CFU/g) in chilled burrata from Italy in France

RASFF

Escherichia coli (130,330,45,490,170 MPN/100g) in chilled mussels (Mitylus galloprovincialis) from Spain in Italy

RASFF Alert – Histamine – Chilled Tuna

European Food Alerts

RASFF

histamine (300.7 mg/kg – ppm) in chilled tuna (Thunnus albacares) from Sri Lanka, via the United Kingdom in Ireland

RASFF Alerts – Salmonella – Black Pepper – Chicken Legs -Chicken Tulips

European Food Alerts

RASFF

Salmonella enterica ser. Abaetetuba (presence /25g), Salmonella enterica ser. Glostrup (presence /25g) and Salmonella enterica ser. Kiambu (presence /25g) in black pepper from Brazil in Germany

RASFF

Salmonella enterica ser. Saintpaul (presence /25g) in black pepper from Brazil in Germany

RASFF

Salmonella (presence /25g) in black pepper from Brazil in the Netherlands

RASFF

Salmonella enterica ser. Enteritidis (presence /25g) in frozen chicken legs from Poland in Romania

RASFF

Salmonella enterica ser. Enteritidis (presence /25g) in frozen chicken tulips from Poland in France

RASFF Alerts – Mycotoxin – Ergot Alkaloids – Rye

RASFF

ergot (Claviceps purpurea) alkaloids (1069 mg/kg – ppm) in rye from Poland in Belgium

RASFF Alert – Animal Feed – Salmonella – Sunflower Meal

European Food Alerts

RASFF

Salmonella (presence /25g) in sunflower meal from Romania in Romania

Research – Listeriosis Caused by Persistence of Listeria monocytogenes Serotype 4b Sequence Type 6 in Cheese Production Environment

CDC

Abstract

A nationwide outbreak of human listeriosis in Switzerland was traced to persisting environmental contamination of a cheese dairy with Listeria monocytogenes serotype 4b, sequence type 6, cluster type 7488. Whole-genome sequencing was used to match clinical isolates to a cheese sample and to samples from numerous sites within the production environment.

USA – Sources of Foodborne Illness Report Released – IFSAC

Click to access P19-2018-report-TriAgency-508.pdf

USA – Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

FDA

Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

To date, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

  • 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
  • 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images below

Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers follow below:

Product name:Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form:16 fl.oz. Amber Bottles

NDC #:052376-021-02

Product Code:1789P

Lots Recalled:ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

Product name:Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form:4 fl.oz. Amber Bottles

NDC #:052376-021-04

Product Code:1788P

Lots Recalled:ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Sunstar Americas Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

Original Press Release

Company Contact Information

Consumers:
Sunstar Americas
 1-800-528-8537
 us.pcr@us.sunstar.com
Media:
Greg Belair
 847-794-4241
 Greg.belair@us.sunstar.com

Product Photos