FDA Investigating 4 Complaints Related To Thyroid Hormone Levels In Dog Food

Consumer complaints about sick pets have spurred nationwide recalls by WellPet LLC and Blue Buffalo Co. because of potentially excessive levels of beef thyroid hormone in their dog foods.

Each company — WellPet LLC of Tewksbury, MA, and Blue Buffalo Co. of Wilton, CT — recalled specific production lots of one flavor of their canned dog food.

The recalled products are:

  • WellPet’s “Wellness 95% Beef Topper for Dogs” in 13.2-ounce cans with best-by dates of “02 FEB 19,” “29 AUG 19” and “30 AUG 19.” The best-by dates can be found on the bottom of the cans.
  • Blue Buffalo’s “Blue Wilderness Rocky Mountain Recipe Red Meat Dinner Wet Food for Adult Dogs” in 12.6-ounce cans with the UPC number 840243101153 and a best-by date of June 7, 2019, on the bottom of the cans.

 

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The Food and Drug Administration is investigating four complaints, one associated with the Blue Buffalo product and three associated with the WellPet product. The investigation revealed the potential “…for elevated levels of naturally occurring beef thyroid hormone” in these products, according to the recall notices.

Thyroid hormone can be introduced into meat through the process of “gullet trimming,” which is the harvest of the neck muscle from the area of the larynx, according to the New England Journal of Medicine.

In 1984-1985, the U.S. Centers for Disease Control and Prevention investigated an outbreak of thyrotoxicosis that affected 121 residents of Minnesota, South Dakota and Iowa. The source of the outbreak proved to be beef trimmings from a plant near Luverne, MN. The meat plant employed gullet trimming to harvest meat from the area of the larynx, a process that resulted in portions of the thyroid being included in the harvested meat.

Based on conclusions from the investigation, the U.S. Department of Agriculture prohibited gullet trimmings in beef and pork for human consumption. Gullets and meat trimmed from the area of the larynx are still permitted in pet food.

Dogs that ingest excessive beef thyroid hormone may exhibit symptoms that include increased thirst and urination, weight loss, increased heart rate and restlessness. Prolonged exposure to high thyroid hormone levels may lead to additional symptoms, such as vomiting, diarrhea, and rapid or difficulty breathing.

These symptoms are similar to those produced by an overactive thyroid.

The recalled Blue Buffalo dog food was distributed nationwide through pet specialty and online retailers. The WellPet dog food was distributed throughout North America online and through pet specialty stores. PetSmart and Pet Food Express have posted recall notices for both products on their websites.

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Evanger’s Pet Food and Against the Grain Voluntarily Recalls Additional Products

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Out of an abundance of caution, Evanger’s Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger’s Braised Beef and Against the Grain’s Pulled Beef Products due to potential adulteration with pentobarbital.  Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.

Evanger’s wants 100% of its products to be 100% safe 100% of the time prompting removal of the products.

The 12 oz. cans of dog foods that are being voluntarily recalled have the following barcodes.  The numbers listed below are the second half of the barcode, which can be found on the back of the product label:

  • Evanger’s: Hunk of Beef: 20109
  • Evanger’s: Braised Beef: 20107
  • Against the Grain: Pulled Beef: 80001

The three products being voluntarily recalled were manufactured between December 2015 and January 2017, and have expiration dates of December 2019 through January 2021.  These products were distributed online and through independent boutique pet stores nationwide.

This voluntary recall affects only Hand Packed Beef Products, which is a unique method in which large chunks of meat are manually placed into the can by hand, not machine.

Consumers may return any can of the aforementioned products to their place of purchase for a full refund for the inconvenience.  For any questions, customers may contact the company at 1-847-537-0102 between 10:00 AM – 5:00 PM Central Time, Monday – Friday.

Distributors and online retailers were previously notified of this voluntary recall on February 27th.

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FDA Approves Diroban, the First Generic Drug to Treat Heartworm Disease in Dogs

February 17, 2017

The U.S. Food and Drug Administration today announced the approval of Diroban (melarsomine dihydrochloride), the first generic drug to treat heartworm disease in dogs.

Heartworm disease is caused by a thread-like parasitic worm called Dirofilaria immitis. The worms are called heartworms because the adult worms live in the heart, lungs, and associated blood vessels of an infected animal. In dogs, the disease results in heart failure, severe lung disease, other organ damage, and death. Heartworm disease is only spread through the bite of a mosquito; it cannot be transmitted directly from one dog to another.

Diroban is administered by deep injection into the back muscles. It is used to treat dogs with stabilized class 1 (no symptoms), class 2 (mild to moderate respiratory symptoms), and class 3 (severe respiratory symptoms) heartworm disease. It should not be used in dogs with class 4 (extremely severe respiratory symptoms) heartworm disease. Side effects of treatment may include pain, swelling, or tenderness at the injection site, coughing/gagging, decrease in activity level, lack of appetite, fever, and vomiting. Dogs should be closely monitored by a veterinarian during treatment. Following treatment, dogs should have restricted exercise for up to six weeks because active dogs are at risk for blood clots in the lungs.

Diroban must be prescribed by a licensed veterinarian because professional expertise is needed to correctly diagnose the severity of a dog’s heartworm disease and administer the drug as part of a treatment plan.

The application for Diroban is sponsored by Anzac Animal Health, LLC and distributed by Zoetis, Inc.

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FDA Cautions Pet Owners Not To Feed Certain Evanger’s or Against the Grain Canned Pet Foods – Must Read!!!!

February 17, 2017

The U.S. Food and Drug Administration is advising pet owners and caretakers not to feed their pets certain lots of Evanger’s canned Hunk of Beef or Against the Grain Grain Free Pulled Beef with Gravy canned dog food after unopened cans from both brands were found to contain pentobarbital, a barbiturate.

Pentobarbital is a drug that is used in animal euthanasia. It should not be in pet food and its presence as detected by the FDA in these products renders them adulterated.

The FDA was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products. Additionally, the agency concluded an inspection of the manufacturing facilities on February 14, 2017, and noted numerous significant concerns with conditions found at both the Wheeling, IL and Markham, IL plants. These are initial observations and do not represent a final agency determination regarding the firm.

Following discussions with the FDA, Evanger’s initiated a voluntary recall on February 3, 2017, of certain lots of its 12-ounce Hunk of Beef canned dog food: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB, all with an expiration date of June 2020.

In the course of the investigation, the FDA tested two cans of Against the Grain brand canned Grain Free Pulled Beef with Gravy dog food manufactured in the same facilities as Evanger’s products and using beef from the same supplier: these samples also tested positive for pentobarbital. On February 9, 2017, after conversations with the FDA, Against the Grain voluntarily recalled lot 2415E01ATB12 BEST DEC 2019 of this product. The company issued a public notice about its recall on February 13, 2017. To date, the FDA is not aware of any pet illnesses associated with the Against the Grain product.

The FDA began investigating Evanger’s Dog & Cat Food Company Inc. when it learned about five dogs in a single household that suffered acute neurological symptoms shortly after eating the product. One dog was euthanized after secondary complications, and three others recovered after receiving veterinary care. One of the dogs treated remains on seizure medication, and the fifth dog that ate the least amount of food recovered with time.

The stomach contents of the deceased dog and an open can of the product were tested by an FDA Veterinary Laboratory Investigation and Response Network lab, and unopened cans of the product from the pet owner and retailer that sold the products (from the same production lot), were tested by FDA’s lab. All of the samples tested positive for pentobarbital.

In its recent press release announcing a limited product recall, Evanger’s Dog & Cat Food Company, Inc. stated that the beef for its Hunk of Beef product came from a “USDA approved” supplier. However, the FDA reviewed a bill of lading from Evanger’s supplier of “Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit For Human Consumption” and determined that the supplier’s facility does not have a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service. The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade. USDA-FSIS regulates slaughter of animals for human consumption only. Testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat used in the product was bovine (beef).

The investigation by the FDA is ongoing and includes examination of the suppliers of beef to Evanger’s and Against the Grain to determine a possible cause for the presence of pentobarbital. The FDA is also coordinating with the USDA to address any possible areas of shared jurisdiction at the suppliers.

Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.

Consumers with cans of product subject to the facilities’ voluntary recalls should refer to the firms’ respective press releases for information about returning the product.

 

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Blue Buffalo Recalling Homestyle Recipe Healthy Weight Chicken Canned Food

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Blue Buffalo Company has issued a voluntary recall for specific lots of Blue Buffalo Homestyle Recipe Healthy Weight due to possible aluminum metal contamination.

The recalled product includes:

  • Blue Buffalo Homestyle Recipe Healthy Weight, Chicken Dinner with Garden Vegetable
  • 12.5 ounce can
  • UPC: 8-40243-10017-0
  • Codes: Best By 08/03/2019 –  The “Best By” date is on the bottom of the can.

No other Blue Buffalo products are involved. The company has not received any reports of illness or injury as a result of the problems giving rise to this recall.

Customers are invited to return the impacted product to your local retailer for a full refund. For additional information, call 866-800-2917.

U.S. citizens can report complaints about FDA-regulated pet food products by calling the consumer complaint coordinator in your area.

Or go to http://www.fda.gov/petfoodcomplaints.

Canadians can report any health or safety incidents related to the use of this product by filling out the Consumer Product Incident Report Form.

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Against the Grain Pulled Beef with Gravy Dinner for Dogs Recalled

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Out of an abundance of caution, Against the Grain Pet Food is voluntarily recalling one lot of Against the Grain Pulled Beef with Gravy Dinner for Dogs that was manufactured and distributed in 2015.

The 12 oz. Against the Grain Pulled Beef with Gravy Dinner for Dogs that is being voluntarily recalled, due to the potential presence of pentobarbital, has an expiration date of December 2019, a lot number of 2415E01ATB12, and the second half of the UPC code is 80001 (which can be found on the back of the product label).

Oral exposure to pentobarbital can cause side effects such as drowsiness, dizziness, excitement, loss of balance, nausea nystagmus (eyes moving back and forth in a jerky manner), inability to stand and coma.

Note: To-date, no complaints have been reported to Against the Grain for this single lot number nor any of Against the Grain’s pet foods, since the company was founded.

In 2015, this one lot of product was distributed to independent pet retail stores in Washington and Maryland, though it has been verified that this lot is no longer on any store shelves. This voluntary recall only affects one specific lot of food.

Consumers may return any can (with the aforementioned lot number) to their place of purchase and receive a full case of Against the Grain food for the inconvenience.

For any questions, customers may contact the company at 708-566-4410 between 11:00 AM – 4:00 PM Central Time, Monday – Friday.

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Cancer Drug for Dogs (Paccal Vet-CA1) No Longer Conditionally Approved

The U.S. Food and Drug Administration is giving notice that the agency is withdrawing the conditional approval for Paccal Vet-CA1 (paclitaxel for injection) at the request of the drug’s manufacturer, Oasmia Pharmaceutical AB. Paccal Vet-CA1 was intended to treat certain mammary and squamous cell carcinomas in dogs that have not received previous chemotherapy or radiation therapy. The conditional approval for Paccal Vet-CA1 is no longer in effect as of February 8, 2017. Paccal Vet-CA1 is now an unapproved animal drug with no legal marketing status and further sales of the drug are illegal.

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