Lax testing practices resulted in vitamin D overdoses in Hill’s and Sunshine Mills pet food

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

Toxic levels of vitamin D in Hill’s Pet Nutrition (Hill’s) canned pet foods and Sunshine Mills (Sunshine) dry pet foods could have been prevented, had both companies followed their own food safety plans.

According to information obtained by Food Safety News in response to Freedom of Information Act (FOIA) requests, Hill’s identified Vitamin Premix as a ‘high risk’ chemical hazard and required that the ingredient “…be analyzed and be within acceptable limits prior to unloading … into the manufacturing facility.”

The company was unable to provide analytical test results for Vitamin Premixes during a February 2019 inspection.

The inspection was undertaken by the U.S. Food and Drug Administration (FDA) in response to the January 31, 2019 Hill’s recall of canned pet foods due to excess levels of vitamin D.

Tests conducted on a retained sample of the premix revealed a level of vitamin D that was roughly 30 times the target range for this ingredient. As of February 11, 2019, the company acknowledged having received 85 consumer complaints reporting pet deaths.

The number of complaints received by the company has increased substantially since that date, according to information supplied to FDA by Hill’s in response to FDA’s inspection observations.

FDA declined to comment on the number of pet deaths. According to an agency spokesperson, FDA is still in the process of verifying details of the complaints it has received, and considers it would be “…premature to release a number until the cases have been vetted to ensure they are all related to recalled product and are indeed cases of vitamin D toxicity.”

Hill’s cited a manufacturing error on the part of its vitamin premix supplier as the cause for the excessive vitamin D levels in its canned pet foods. The company is reevaluating and strengthening its specifications, including requiring a Certificate of Analysis for each incoming shipment of vitamin and trace mineral premixes.

In December 2018, FDA issued an alert to pet owners regarding a series of dry dog food recalls for excessive vitamin D levels. As reported by Food Safety News, FDA received a total of six dog illness reports associated with the recalled products.

The dry dog foods were manufactured by Sunshine Mills and sold under several brand names.

An ordering error by a Sunshine employee caused the wrong Vitamin D ingredient to be shipped to the company.

According to FDA, Sunshine did not follow its own written procedures for receiving ingredients. The company neither obtained a Certificate of Analysis for the ingredient, nor conducted its own testing to determine whether the Vitamin D it received was the correct concentration for use in dog food.

The error resulted in a level of Vitamin D in the finished dog foods of as much as 70 times the target amount.

Sunshine was notified on October 23, 2018 about a consumer complaint reporting an ill dog that had eaten one of the company’s dry dog foods. Sunshine investigated the complaint and concluded on November 2nd that it was valid.

FDA requires validated complaints to be reported within 24 hours; however, Sunshine did not submit a ‘reportable food report’ to FDA until six days later, on November 8, 2018.

Although the sources of elevated vitamin D were different in these two situations, the course of events was similar.

  • Both Hill’s and Sunshine took delivery of an ingredient that was substantially higher in vitamin D than specified for the purpose.
  • Both Hill’s and Sunshine had written procedures in place for receiving raw materials, and these procedures mandated testing for vitamin D concentration.
  • Neither Hill’s nor Sunshine carried out the lab analysis mandated in their written procedures.
  • Neither Hill’s nor Sunshine required a Certificate of Analysis for their Vitamin D ingredient or premixes.
  • Had Hill’s and Sunshine followed their own written procedures, the incorrect vitamin D ingredient concentration would have been found before the ingredient was used.

FDA’s investigation into Hill’s is ongoing, according to an agency spokesperson.

FDA offers the following information regarding vitamin D toxicity to pet owners and veterinarians.

  • If your pet is having symptoms of vitamin D toxicity, contact a veterinarian immediately. 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.
  • Consumers 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.
  • The FDA encourages veterinarians treating vitamin D toxicity to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostics. You can submit these reports electronically through the 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.
  •  Veterinarians should also be aware that vitamin D toxicity may present as hypercalcemia, similar to dogs that have consumed rodenticide. In these cases, FDA suggests that veterinarians confirm diet history to verify whether the dog has been eating any of the recalled products.

For a comprehensive list of Hill’s Pet Nutrition canned pet foods recalled due to excessive Vitamin D, please visit Hill’s Pet Nutrition recalls: Country-by-country breakdown on eFoodAlert

Hill’s expanded dog food recall impacts pet families worldwide

This story by Phyllis Entis first appeared on Food Safety News and is reposted with permission

Hill’s Pet Nutrition (Hill’s) expanded its worldwide recall late last week to include 85 total lots of 33 varieties of canned, wet dog food, according to a U.S. Food and Drug Administration (FDA) recall notice dated March 21, 2019.

The recall impacts Hill’s customers in at least 78 countries, according to information posted on Hill’s own websites, and the European Union’s Rapid Alert System for Food and Feed (RASFF).

An updated list of recalled products sorted by country is available at eFoodAlert.

Hill’s expanded its recall after FDA requested that the company test the vitamin D levels in additional products that were not part of the original recall. Testing leading up to both the January 31st and March 20th recalls revealed excessive, potentially toxic amounts of vitamin D, according to FDA.

All of the recalled products were manufactured using the same vitamin premix from a single U.S.-based supplier, according to Hill’s.

Although several hundred pet owners have posted complaints on the Hill’s Facebook page in response to the recall notice, there is no official tally of the number of affected pets.

In response to a question from Food Safety News, a spokesperson for FDA offered the following statement:

“The FDA has received a number of reports since the first Hill’s recall press release was issued on January 31, 2019. We are in the process of verifying the details of the complaints and it would be premature to release a number until the cases have been vetted to ensure they are all related to recalled product and are indeed cases of vitamin D toxicity.”

According to the FDA, dogs suffering from vitamin D toxicity may vomit, have little appetite, drink and urinate more, drool excessively, and/or lose weight. The severity of the symptoms and the speed of onset depends on the concentration of vitamin D ingested.

A dog exhibiting these symptoms should be seen by a veterinarian immediately.

Duncan’s story

Duncan was a 13-year old lascho bichon, a service dog trained for seizure alert, and Kelly’s constant companion.

Kelly and Duncan divided the year between their homes in Michigan and Florida. They walked together, rode golf carts together as many as four times a day.

Twelve years ago, as Kelly told Food Safety News, Duncan suffered from pancreatitis and was prescribed Hill’s Science Diet by his veterinarian. He ate Hill’s I/D and Z/D wet and dry foods.

In early January, Duncan started to vomit white foam, had excessive thirst and urination and was lethargic. The next morning, he awakened with tremors.

Over the next three days, during which Kelly brought Duncan to the veterinarian three times, Duncan lost excessive weight and his condition deteriorated.

Three weeks after Duncan’s death, Kelly read about the Hill’s recall. She contacted the company on February 6, and was offered compensation consisting of $10.00 in coupons for the purchase of Hill’s pet food.

Because Duncan died weeks before the recall was announced, there was no necropsy and no suspicion at the time that his death was due to vitamin D toxicity.

When asked by Food Safety News what message she wished to share with other pet parents, Kelly replied:

“Hill’s claims they subject all of their food to extensive and repeated testing. Yet, now they have admitted that they sold food contaminated with Vitamin D. Obviously, Hills did NOT have testing and quality controls in place to check the food before they put it on the shelves for sale. Also, they dragged their feet issued the three waves of the recall, with the last wave coming on March 20th. During that delay, additional pets were fed this poisoned food and have died. And, the recalls still don’t include all of the contaminated food. Why would anyone trust them now? Go to the Hills Pet Nutrition Facebook page and read the thousands of comments underneath the two recall notices from angry pet owners.”

Kelly has set up a Facebook Group, Saving Pets One Pet @ A Time, in Duncan’s memory where pet owners can comment on their experiences and share information about nutritious pet food options.

What pet owners should do

  •  If your pet is exhibiting symptoms of vitamin D toxicity, contact a veterinarian immediately. 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.
  • Do not feed the recalled product to your pets. When discarding recalled products, make sure that they cannot be accessed by children, pets or wildlife. * Pet owners 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 veterinarians should do

  • Ask your clients for a diet history if you suspect vitamin D toxicity, which may present as hypercalcemia.
  • Do not sell the recalled foods to your clients, and contact the manufacturer for further instructions. The FDA also encourages veterinarians to contact clients who have purchased recalled products, if they have the means to do so (such as through medical records or sales receipts).
  • FDA welcomes case reports, especially those confirmed through diagnostics. You can submit these reports electronically through the 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.

Recalls and Alerts: March 18 – 23, 2019

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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WORLDWIDE CANNED DOG FOOD RECALL: Hill’s Pet Nutrition has expanded its January 31, 2019 recall to include additional products and batch codes. Please visit eFoodAlert’s update post for a complete list of affected products, sorted by country.

United States

Allergy Alert: Century Snacks, LLC recalls Snak Club Honey Bliss Nut Mix (3oz and 5.75oz pkgs; All batches) due to undeclared milk.

Allergy Alert: Better Made Snack Foods recalls Original Potato Chips (10-oz pkg; Lots 62090431442 thru 62090431520 and Lots 85100431442 thru Lot # 85100431520) due to undeclared milk.

Allergy Alert: Tip Top Poultry, Inc. recalls Gordon™ CHOICE All Natural* Diced White Chicken Meat (10-lb. case containing two 5-lb. plastic bag packages; Case code 599697; PACKDATE 02/15/19) due to undeclared soy.

Food Safety Recall: Two Brothers Pork Skins recalls an undetermined amount of pork skin products because the products were produced without meeting the federal requirements to develop and implement a hazard analysis and system of preventive controls (HACCP) to improve the safety of the products. Please refer to the recall notice for a complete list of affected products, which were shipped to a distributor and retail locations in North Carolina and South Carolina.

Food Safety Recall: Tyson Foods, Inc. recalls approximately 69,093 pounds of frozen, ready-to-eat chicken strip products due to extraneous matter (pieces of metal) contamination. Please refer to the recall notice for a complete list of affected products, which were shipped to retail locations nationwide and for institutional use in locations in Michigan and Washington.

Food Safety Recall: La Rosita Fresh Market Inc recalls MOLIDA DE RES GROUND BEEF (varying weights; Packed On 3/13/19 Sell By 3/20/19 or Packed On 3/14/19 Sell By 3/21/19) due to E. coli O157:H7 contamination.

Food Safety Recall: Henry Avocado recalls California-grown whole avocados due to potential Listeria monocytogenes contamination. The recalled avocados were distributed in Arizona, California, Florida, New Hampshire, North Carolina and Wisconsin and sold in bulk in retail stores.

Food Safety Recall: North Country Smokehouse recalls approximately 2,686 pounds of ready-to-eat sausage products due to foreign matter (metal) contamination. Please refer to the recall notice for a complete list of affected products.

Pet Food Safety Recall: Hill’s Pet Nutrition expands its January 31, 2019 canned pet food recall to include additional products and date codes, due to elevated Vitamin D levels. Please refer to the recall notice for a complete list of affected products.

OTC Pharmaceutical Safety Recall: Kingston Pharma, LLC recalls DG™/health NATURALS baby Cough Syrup + Mucus (2 fl. oz / 59ml; Lot #KL180157) due to Bacillus cereus and Bacillus circulans contamination.

Canada

OUTBREAK ALERT / Food Safety Recall: Sofina Foods Inc. recalls Janes brand Pub Style Chicken Nuggets (800g; Best before 2019 DE 15; UPC 0 69299 12490 3) due to possible Salmonella contamination. There have been reported illnesses associated with the consumption of this product.

Allergy Alert: Pur-Natural Ingredients of Canada recalls Pur-Naturals brand Bone Broth Protein – Chocolate and Pur-Naturals brand Bone Broth Protein – Vanilla (454g; All lots) due to undeclared milk.

Food Safety Recall: Les Fermes Valens inc recalls pepperette (variable weight; all product sold up to March 22, 2019) due to improper storage conditions.

Food Safety Recall: Monster Energy Canada Ltd recalls Monster Energy brand Caffé Monster Salted Caramel Energy Drink (405 ml; Best before JA2120 BF AJA2120 BF BJA2220 BF AJA2220 BF B; UPC 0 70847 03184 0) due to foreign matter (pieces of glass) contamination.

Food Safety Recall: OM Foods Inc recalls Organic Matters brand teas due to Salmonella contamination. Please refer to the recall notice for a complete list of affected products and batch codes.

Food Safety Recall: Olymel S.E.C. / L.P. recalls Certain chicken breast strip products due to undercooking. Please refer to the recall notice for a complete list of affected products.

Europe

Allergy Alert (Belgium): Dewartiest recalls various Dewartiest brand Frozen Cheese Croquettes due to undeclared lupine. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (Belgium): SITA SCRL recalls Menu brand CREMA DI OLIVE VERDI (390g; Lot LP.264; Expiry 09/2020) due to undeclared wheat (gluten).

Allergy Alert (Belgium): Sligro – ISPC Belgium recalls Daendels brand Luxe Notenmelange / mixed nuts (850g; Lot #18433; Best before 21-04-2019) due to undeclared peanuts.

Allergy Alert (Denmark): House Doctor A/S recalls Hummus, Beetroot & Pistachios and Hummus, Carrots & Dill (130g; Use by 14.05.2019 and 23.05.2019) due to undeclared sesame.

Allergy Alert (Denmark): Bønnelykken A/S recalls Meal Quick Base Green Cauliflower salad with an oriental twist (370g; Lot #22.03.2019; Use by 22.03.2019) due to undeclared gluten, milk and soy.

Allergy Alert (Denmark): Lidl Danmark K/S recalls Ferrero Raffaello (260g; All date codes) due to undeclared almonds, skimmed milk powder, whey powder (milk), wheat flour (gluten) and soy.

Allergy Alert (Denmark): Salling Group recalls Amora Kaffeeweisser Coffee cream substitute (Best before 31-05-2020) due to undeclared milk.

Allergy Alert (Denmark): Salling Group recalls Ready to EAT salad, Grilled chicken fillet, pasta and yoghurt dressing (Use by 24-03-19) due to undeclared mustard.

Allergy Alert (France): SIMON DUTRIAUX recalls SIMON DUTRIAUX brand Tartinable de Poulet sauce curry (150g and 1kg; Lots 907141211 and 907110011; Best before 12/04/2019) due to undeclared celery.

Allergy Alert (Germany): Gartenfrisch Jung GmbH recalls EDEKA deli Caesar Snack Salad (280g; Best before 23.03.2019) due to undeclared skim milk yoghurt, hard cheese, egg yolk, anchovy paste, milk, lysozyme (from egg) and wheat flour.

Allergy Alert (Ireland): Manufacturer recalls Terry’s Chocolate Orange (157g; Best before 11/03/2020; Batch code M201131) due to undeclared hazelnut.

Allergy Alert (Ireland): Clive’s Pies recalls Clive’s Cake Organic Chocolate Brownie (65g; All dates) due to undeclared milk.

Allergy Alert (Netherlands): Albert Heijn and Etos recall Care Cranberry capsules & Etos Cranberry capsules due to undeclared peanut.

Allergy Alert (UK): London Fields Brewery recalls Hackney Hopster Beer (330 ml cans and 330 ml bottles; All date codes up to and including 4 December 2019) due to undeclared wheat (gluten) and oats (gluten).

Allergy Alert (Romania): S.C. Spicul-Etap S.A. recalls Biscuiti Populari (140g; Expiry 10.12.2019) due to undeclared sulfites.

Allergy Alert (Sweden): Paulig Foods recalls Risenta Chia seeds (170g; Batch #4001258) and Risenta Organic Sunflower kernels (350g; Batch #4001258) due to undeclared sesame.

Allergy Alert (UK): Café Class recalls various sandwiches and bakery products due to undeclared mustard and/or sesame and/or egg and/or milk. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (UK): Clive’s Pies recalls Clive’s Cake Organic Chocolate Brownie (65g; All dates) due to undeclared milk.

Food Safety Recall (Belgium): Delhaize recalls Crottin de Chavignol cheese (60g; Lot #L 033 09; Best before 05/04/2019) due to E. coli O26 contamination.

Food Safety Recall (Belgium): Delhaize recalls Delhaize Filet d’Anvers Supérieur (110g; All lots with best before dates up to and including 08/04/2019) due to E. coli contamination.

Food Safety Recall (Belgium): Industry recalls Pasco Tandoori Marinade Paste curry paste (270g glass jar; Lot #811170; Expiry date novembre 2021) due to foreign matter (glass pieces) contamination.

Food Safety Recall (Denmark): Delika A/S recalls Rema 1000 brand natural chicken sandwich slices (125g; Best before 20.03.2019, 21.03.2019, 26.03.2019, 27.03.2019) due to foreign matter (metal) contamination.

Food Safety Recall (Denmark): Hilton Foods A/S recalls Coop 365 Ecology Fresh organic beef sausages merguez (300g; Use by 26.03.2019) and Coop Tatar minced meat, below 6% fat (180g; Use by 22.03.2019) due to Salmonella contamination.

Food Safety Recall (France): ALDI recalls Petit Furet brand Meringuettes Flocons / Meringue Flakes (Lot #L8339; Best before 30/12/20) due to foreign matter (pieces of wood) contamination.

Food Safety Recall (Germany): Penny Markt GmbH recalls SAN FABIO Grana Padano, grated (150g; Best before 06/17/2019) due to foreign matter (wood splinters and small white plastic pieces) contamination.

Food Safety Recall (Ireland): Zakład Handlowo-Usługowy “Tadex” Tadeusz Koniak recalls Wafle suche (170g; All batches with ‘best-before’ dates from 7/09/2019 to 22/09/19) due to possible Salmonella contamination.

Food Safety Recall (Luxembourg): Supermarchés Delhaize recalls Laiterie Triballat brand Crottin de Chavignol (60g; Lot #L 033 09; Best before 05/04/2019) due to E. coli O26 contamination.

Food Safety Recall (Netherlands): Jan Linders recalls Jan Linders grated cheese, young, aged 48+ (175g; Best before 26-06-2019) due to foreign matter (pieces of blue plastic) contamination.

Food Safety Recall (Romania): OCEAN FISH SRL recalls Blue Shark brand Smoked Salmon (100g; Lot #08032019; Best before 08.03.2019) due to Listeria monocytogenes contamination.

Food Safety Recall (UK): Oatly UK Limited recalls Oatly Oat Drink Whole (1L; Best before 29 April 2019) due to foreign matter (metal pieces) contamination.

Pet Food Safety Recall (UK): Hill’s Pet Nutrition Ltd extends its earlier recall of canned, wet dog food to include additional products and batch codes due to elevated vitamin D levels. Please refer to the recall notice for a complete list of affected products.

Australia and New Zealand

Food Safety Recall (Australia): Meals on Wheels SA recalls all frozen meal products due to Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Australia): Bridgewater Poultry recalls various brands of shell eggs due to potential Salmonella Enteritidis contamination. Please refer to the recall notice for a complete list of affected products. This recall is linked to the investigation of an outbreak of Salmonella Enteritidis illnesses in NSW, Victoria, Queensland and Tasmania.