Darwin’s Pet Food pathogen problems ongoing for 14 months

Judy, who owns Blitz the German shepherd, took this photo of Darwin’s brand raw dog food when she opened it and noticed it was off-color.

Since October 2016, Darwin’s Natural Pet Food has recalled eight production lots of raw pet food. In all, the manufacturer recalled more than 23 tons of cat and dog food during a 14-month period.

The recalls include seven dog foods and one cat food. Customers who purchased the recalled products were notified of the recalls by email — two to three months after the production dates of each batch. No recall notices were posted for the general public on the company’s website or the Food and Drug Administration’s website.

Darwin’s has not responded to a request for comment on their recalls or their follow-up actions.

The company, incorporated under the name Arrow Reliance Inc., recalled the pet foods because of positive test results showing Salmonella and/or Listeria monocytogenes. The bacteria can cause serious infections in people who handle the pet food. It can also contaminate surfaces, containers and utensils, which can spread the bacteria to foods, hands and anything coming into contact with the contaminated items.

Several of Darwin’s customers say there were product safety and package quality issues that predate the latest round of recalls.

Judy’s story
Judy adopted Blitz, an abandoned German shepherd, from an Orange County, California rescue organization in June 2012. Described by his owner as a gentle giant, he is thought to be 7 to 9 years old. About a year ago, he became partially paralyzed after developing inter-vertebral disk disease. He gets around with the aid of a special wheelchair and loves to swim.

Judy has been a customer of Darwin’s since 2012-2013. The food agreed with Blitz. His coat was soft, his stools were normal, and he didn’t itch.

About a year ago, Judy noticed a change in the Darwin’s products. The packaging was leaky, and the meat quality appeared to have deteriorated. She reported her concern to a company representative, who offered to reimburse her for the leaky packages of dog food.

According to Judy, Blitz began to suffer bad bouts of diarrhea in April 2017. He was treated with antibiotics on the assumption he was infected with giardia. Despite treatment, Blitz continued to suffer cycles of diarrhea, and was recently lab-diagnosed with a Salmonella infection.

Judy was never notified of the recalls, as she had not received any of the recalled production lots. Upon contacting the company by email after learning about the recalls, she was assured that leaky and off-color packages of meat she had been sold were “good to use.” She is now working directly with the Food and Drug Administration regarding the situation.

“I just want good, healthy food for my dog,” Judy said. “Is that so much to ask?”

Jerry’s story
Jerry volunteers at the German shepherd rescue center where Blitz was adopted. His 7-year-old German shepherd, Yavol, was 4-months-old when Jerry rescued her.

Yavol has been eating Darwin’s products for more than a year. She has suffered many bouts of lethargy, lack of appetite, diarrhea and vomiting. Yavol has been treated multiple times with generic flagyl and, on a few occasions, with antibiotics, but her digestive problems have persisted.

For the past six months or more, the Darwin’s products Jerry has been getting have had leaking packages and off-colored meat. He reported the issues to the company on multiple occasions. After being told at first that the product was safe to use, he persisted and was eventually supplied with replacement packages as compensation for the off-color and leaky packages.

Jerry did not receive notification of any recalls from the company.

Darwin’s recalled products as of Dec. 21, 2017
Darwin’s Natural Selections brand, frozen, raw Turkey with Organic Vegetable Meals for Dogs

Package size: 2 lbs.
Number of packages recalled: 1192
Date recall initiated: 10/17/2016
Manufacturing date: 7/20/2016
Lot number: 3142070
Reason for recall: Listeria monocytogenes

Darwin’s Natural Selections brand, frozen, raw Beef with Organic Vegetables Meals for Dogs

Package size: 2 lbs.
Number of packages recalled: 2391
Date recall initiated: 10/17/2016
Manufacturing date: 7/21/2016
Lot number: 3146070
Reason for recall: Listeria monocytogenes

ZooLogics brand, frozen, raw Turkey with Vegetable Meals for Dogs

Package size: 2 lbs.
Number of packages recalled: 1337
Date recall initiated: 10/17/2016
Manufacturing date: 7/25/2016
Lot number: 3155070
Reason for recall: Listeria monocytogenes

Natural Selections Duck Meals for Cats, frozen

Package size: 2 lb. net weight flexible film, partitioned into 4 quadrants
Number of packages recalled: 1560
Date recall initiated: 9/8/2017
Manufacturing date: 06/01/2017
Lot number: 38277
Reason for recall: Salmonella

Natural Selections Chicken with Organic Vegetables Meals for Dogs

Package size: 2 lb. net weight flexible film, partitioned into 4 quadrants
Number of packages recalled: 6,306
Date recall initiated: 12/4/2017
Manufacturing date: 09/26/2017
Lot number: 40727
Reason for recall: Salmonella and Listeria monocytogenes

Natural Selections Duck With Organic Vegetables Meals for Dog

Package size: 2 lb. net weight flexible film, partitioned into 4 quadrants
Number of packages recalled: 3,924
Date recall initiated: 12/4/2017
Manufacturing date: 09/29/2017
Lot number: 40487
Reason for recall: Salmonella

Natural Selections Turkey With Organic Vegetables Meals for Dogs

Package size: 2 lb. net weight flexible film, partitioned into 4 quadrants
Number of packages recalled: 7123
Date recall initiated: 12/4/2017
Manufacturing date: 08/24/2017 and 09/20/2017
Lot number: 39937 and 40507
Reason for recall: Salmonella

What consumers need to know
Consult the list of recalled products and do not feed your pet any food that has been recalled by the manufacturer.

Do not feed your pet any food that appears to be spoiled, off-color, off-odor, or otherwise defective.

Take special care to avoid any drippings from thawed food that could contaminate your work surfaces.

If your pet is suffering from diarrhea, be extra careful about washing your hands before handling or preparing food.

FDA tips on using raw pet food
Because raw pet food is more likely than other types of pet food to contain Salmonella, Listeria monocytogenes and other pathogens, the single best thing consumers can do to prevent infection is to not feed pets a raw diet. However, the FDA Center for Veterinary Medicine is aware that some people prefer to feed their pets this type of diet.

If you choose to feed raw pet food to your pet, be aware that you can infect yourself with Salmonella or Listeria by spreading microscopic amounts of the bacteria from the contaminated food to your mouth.

For instance, you may accidentally ingest the bacteria if you touch your mouth while preparing the raw food or after handling a contaminated utensil. If you get Salmonella or Listeria on your hands or clothing, you can’t see it or smell it, but you can spread the bacteria to other people, objects and surfaces.

To prevent infection with Salmonella and Listeria

Thoroughly wash your hands with soap and water for at least 20 seconds after handling raw pet food, and after touching surfaces or objects that have come in contact with the raw food. Potential contaminated surfaces include countertops and the inside of refrigerators and microwaves. Potential contaminated objects include kitchen utensils, feeding bowls and cutting boards.
Thoroughly clean and disinfect all surfaces and objects that come in contact with raw pet food. First wash with hot soapy water and then follow with a disinfectant. A solution of 1 tablespoon of bleach to 4 cups of water is an effective disinfectant. For a larger supply of the disinfectant solution, add ¼ cup bleach to 1 gallon water. You can also run items through the dishwasher after each use.

This article first appeared on Food Safety News and is reposted here with permission.

Dog food recalled for Salmonella, Listeria monocytogenes; pet owners also at risk

Darwin’s Natural Pet Products has recalled specific production lots of its Natural Selections brand Meals for Dogs after laboratory testing detected Salmonella and Listeria monocytogenes in samples of the products.

People who have handled the dog food are at risk of Salmonella infection and are advised to seek medical attention immediately if they develop symptoms of salmonellosis. Symptoms can include nausea, vomiting, abdominal cramps, diarrhea that is watery or bloody, fever and headache.

recalled-Darwins-Natural-Selections-raw-dog-food Countertops, utensils and pet food and water bowls should be throughly washed to prevent cross-contamination.

A search of the US Food and Drug Administration (FDA) Enforcement Report web page revealed the following products have been recalled by direct email communication with customers:

Natural Selections Duck Meals for Cats, frozen (2-lb. packages; Lot #38277; Mfg. Date: 06/01/17 ) – contaminated with Salmonella
Natural Selections Chicken with Organic Vegetables Meals for Dogs (2-lb. packages; Lot #40727; Mfg. Date: 09/26/17) – contaminated with Salmonella and Listeria monocytogenes
Natural Selections Duck With Organic Vegetables Meals for Dogs (2-lb. packages; Lot #40487; Mfg. Date: 09/29/17) – contaminated with Salmonella
Natural Selections Turkey With Organic Vegetables Meals for Dogs (2-lb. packages; Lot #39937 & #40507; Mfg. Dates 08/24/17 & 09/20/17) – contaminated with Salmonella.

Darwin sells and ships its products directly to customers. Its trademark is held by a Tukwila, WA, company, Arrow Reliance Inc. Darwin’s brand products are not available in stores, nor sold to distributors, according to the company. The recalled products were shipped to customers in September and early October.

Customers who were supplied with the affected products were notified of the recalls by email, with telephone follow-up where necessary, according to the company. No public recall notice was issued, although some information regarding the recall has been posted on Darwin’s Facebook page.

According to information posted on Darwin’s Facebook page, the company does not test “each and every batch of product” at present, but is re-evaluating its current processes in light of the current situation.

The Food and Drug Administration is aware of the recall, according to an agency spokesperson.

Between October 2010 and July 2012, FDA surveyed more than 1,000 samples of pet foods and pet treats for the presence of food-borne disease bacteria, including Salmonella. Of the 196 samples of raw pet food tested during the study, 15 were positive for Salmonella.

On July 16, 2013, FDA issued a “Compliance Policy Guide for Salmonella in Food for Animals,” affirming a zero-tolerance policy for Salmonella in pet food due to the risk to human health.

This report first appeared in Food Safety News and is reposted here with updates with permission.

Evanger’s proposes donating recalled pet food. FDA says ‘no’

The United States Food and Drug Administration (FDA) has vetoed a proposal by Evanger’s Dog and Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for pentobarbital.

The proposal was revealed in a June 29, 2017 Warning Letter issued by FDA, and released on its website Tuesday morning (July 4, 2017) under the agency’s standing policy to post recent Warning Letters on a weekly basis.

The letter addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “…serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.

In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “…sufficient assurance that the remaining units are not adulterated.”

After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all remaining recalled product.

The Warning Letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food that had been fed to all five of the animals, revealed the presence of a ‘large quantity’ of pentobarbital in both samples.

FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, Illinois on January 10, 2017.

On February 14, 2017, the inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:

• Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12 oz. can (Lot #1816E06HB13)
• Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12 oz. can (Lot #2415E01ATB12; BEST DEC 2019)
• Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat
• Pitted, cracked and damaged floors
• Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing
• Inadequate temperature controls

In addition to the two pentobarbital-positive samples cited in the February 14th Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:

• Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
• Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
• Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
• Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
• Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

On March 3, 2017, Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.

In correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, 5/18/2017 and 5/23/2017, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the Warning Letter, are those FDA found to be inadequate or unacceptable.

Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat.

Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.

Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “…well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.”

FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.

Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated.

FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.

Evanger’s now requires new and current suppliers to provide letters of guarantee for their products.

FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.

As is customary, the Warning Letter concludes with a requirement that Evanger’s must furnish a written reply within fifteen working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.

The complete text of the Warning Letter can be found on the FDA website.

This article first appeared in Food Safety News and is reposted here with permission.