One more step forward in Hill’s class action lawsuits. Will DSM be next?


The Class Action suit against Hill’s Pet Nutrition, Inc., has taken another step forward in the legal process with the appointment on July 31st of Lead Counsels for the Plaintiffs and the Defendants.

Lead Counsels for the Plaintiffs are:

The Multidistrict Litigation consolidates approximately 20 individual Class Action suits initiated by grieving dog owners whose pets died as a result of vitamin D overdose.

During the first half of 2019, Hill’s Pet Nutrition recalled 33 varieties of canned, wet dog food due excessive levels of vitamin D in the products.

At present, Defendants named in the Class Action include Hill’s Pet Nutrition, Inc., Hill’s Pet Nutrition Sales, Inc., and Colgate-Palmolive Company.

Hill’s is a subsidiary of Colgate-Palmolive.

The toxic concentrations of vitamin D were found to have originated from a formulation error in the vitamin D premix supplied to Hill’s by the Fort Worth, Texas facility owned by DSM Nutritional Products, LLC. 

An employee at the Fort Worth plant added vitamin D to the premix instead of adding vitamin E, resulting in a 2900% excess of vitamin D in the premix.

FDA follow-up discussions with company management established that DSM did not have adequate systems in place to prevent this type of operator error. For example,

  • Although batch records were reviewed and signed off, the ingredient substitution was not caught either by the
  • The vitamin D and vitamin E ingredients were similar in color, and there was no color-code labelling system in place to differentiate the ingredients
  • DSM did not have a bar coding system in place to aid in identification and tracking of ingredients
  • DSM did not provide a Certificate of Analysis for each batch of premix supplied to Hill’s and does not test every finished batch

As of mid-April, DSM was preparing a revised food safety plan, which it promised to provide to FDA by the end of May.

DSM has not yet been named as a Defendant in the Class Action. It will be up to the Co-Lead Counsels to decide whether or not to do so.

The best last word in this saga belongs to Jessica Hensley of FDA, who told DSM representatives, Your products killed life. Be sure that you have a process in place so that an employee can’t screw it up.

 

 

 

Hill’s Vitamin D Catastrophe – A Preventable Tragedy


On August 16, 2018, DSM Nutritional Products, Inc. in Fort Worth, Texas manufactured two production lots of vitamin premix intended for use in dog food.

Due to a manufacturing error, the premix contained vitamin D at 2900% over the target concentration level.

The two batches of premix, comprising a total of 2.7 tons of material, were destined for a single customer – Hill’s Pet Nutrition Inc. in Topeka, Kansas.

The vitamin premix was used over a period of several months to manufacture 86 total lots of 33 varieties of canned, wet dog foods, under the Hill’s Prescription Diet and Hill’s Science Diet brands.

Those 86 lots, which were distributed across the United States and to 65 other countries around the world, contained toxic levels of Vitamin D.

Hill’s recalled the affected products in three separate announcements, the first in January 2019, the second in March 2019 and the third in May 2019.

In February 2019, Hill’s acknowledged to FDA inspectors that the company had received 85 consumer complaints reporting pet deaths associated with their dog food.

Those 86 lots were most probably responsible for hundreds of pet deaths and even more pet illnesses, causing pet owners unimaginable heartache and costing many thousands of dollars in veterinary bills.

DSM COULD HAVE PREVENTED THIS TRAGEDY

Had DSM carried out its responsibilities under the Food, Drugs & Cosmetics Act to evaluate foreseeable hazards and to implement preventive controls, the company would not have produced or supplied the faulty premix.

The Inspection Observations report, issued upon completion of FDA’s inspection in February 2019 and obtained by eFoodAlert in response to a Freedom of Information Act request, identified two deficiencies, quoted in full.

OBSERVATION 1

You did not evaluate each known hazard or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack, or hold in your facility.

Specifically, your Hazard Analysis indicates the likelihood of using excessive Vitamin d in your premix (intended for use in dog food) to have a probability of occurring once in [REDACTED]. Your estimate is too low because your firm produced a super-potent premix on 8/16/2018 containing Vitamin D at a 30-fold excess that resulted in a Class I product recall on 1/31/2019.

OBSERVATION 2

You did not identify or implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.

Specifically, Vitamin D is an ingredient used in your premixes intended for use in dog food. You made two batches of the premix on 8/16/2018 (total of [REDACTED lbs) that proved to contain Vitamin D at 2900% concentration over the target level. These batches were shipped from your facility in Fort Worth, TX to your customer in [REDACTED]. A preventive control such as reconciliation of Vitamin D usage at a specified frequency could have prevented the contamination of these batches. (emphasis added)

HILL’S IGNORED ITS OWN SAFETY PLAN

If Hill’s had carried out the preventive controls specified in its own food safety plan, the company would have detected the toxic level of vitamin D present in the DSM premix batches.

As previously reported by eFoodAlert, Hill’s own written procedures called for vitamin D testing of the premix. However the company was unable to provide any evidence to FDA inspectors that those tests had been carried out.

Hill’s did not verify vitamin D levels either the premix or in their finished product until after receiving a consumer complaint on December 28, 2018.

THE BOTTOM LINE

The story is not yet done.

The race is not yet run.

The lawsuits have just begun.

Recalls and Alerts: July 25 – 27, 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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United States

OUTBREAK ALERT/FOOD SAFETY RECALL: CDC is investigating an 11-state outbreak of 132 Cyclospora illnesses linked to consumption of fresh basil from Mexico. FDA has requested a recall of fresh basil exported by Siga Logistics de RL de CV located in Morelos, Mexico. Outbreak victims were exposed to the contaminated fresh basil at restaurants in Florida, Minnesota, New York and Ohio.

Allergy Alert: JuJu Bakes, LLC, DBA The Cookie Dough Cafe recalls Chocolate Chip Chilled Gourmet Edible Cookie Dough Bars (1.6 oz; Lot #19177; Expiration date 01/22/20; UPC 850967006531) due to undeclared peanuts.

Allergy Alert: Home Market Foods, Inc. recalls approximately 53,217 pounds of frozen ready-to-eat beef and pork meatball products due to undeclared milk and wheat.

Allergy Alert: Euphoria Fancy Food Inc recalls Tainy Vostoka Assorted Dry Fruits-Apple (500g; Container code #21 01 19 SS; UPC 4605932006197) due to undeclared sulphites.

Food Safety Recall: Williams Foods LLC recalls Great Value Mild Taco Seasoning Mix (1 oz; Best if used by 07/08/21 & 07/09/21; UPC 0 78742 24572 0) and HEB Taco Seasoning Mix Reduced Sodium (1.25 oz; Better by 07/10/21, 07/11/21 & 07/15/21; UPC 0 41220 79609 0) due to possible Salmonella contamination.

Food Safety Recall: Premium Foods USA, Inc. recalls approximately 76,025 pounds of various Siluriformes fish products that were not presented for import re-inspection into the United States. In addition, the products were imported from Bangladesh and Myanmar, countries ineligible to export Siluriformes fish product to the United States. Please refer to the recall notice for additional details.

Pet Treat Safety Recall: Lennox Intl Inc recalls Natural Pig ears (All product shipped to nationwide distributors and/or retail stores from May 1st, to July 3rd, 2019) due to Salmonella contamination. The recalled product appear to be linked to two dog illnesses, which may be associated with an outbreak of multiple Salmonella serotypes illnesses in humans associated with bulk pig ear dog treats.

Canada

Allergy Alert: TJX Canada recalls Skinnygirl brand Belgian Dark Chocolate Truffles – Dark Chocolate Almond (102g; UPC 8 51342 00660 7; Lot #9035 & 9063; Best by 07/04/2020 and 09/04/2020, respectively) due to undeclared milk.

Allergy Alert: Redfrog Enterprises Ltd. recalls Wang Korea Buldak Bong Fish Sausage (340g; Product code FEB.08.2020; UPC 087703221536) and Wang Korea BBQ Bong Fish Sausage (340g; Product Code FEB.08.2020; UPC 087703221543) due to undeclared egg.

Food Safety Recall: Agropur Cooperative recalls Idéale brand, Iceberg Premium brand and Originale Augustin brand ice cream and frozen yogurt products due to foreign matter (fine metal particles) contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Boucherie J.C. Fortin inc. recalls PEPPERETTE MAISON (All product with best before dates up to and including August 1, 2019) due to inadequate storage temperature.

Food Safety Recall: Delta Pacific Seafood Ltd. recalls Western Family brand Original Wild Sockeye Smoked Salmon Nuggets (150g; Product codes 11720516 and 11720517; UPC 0 62639 35065 9) due to Listeria monocytogenes contamination.

Food Safety Recall: Associated Grocers recalls certain Celebrate brand frozen profiteroles and eclairs due to Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Europe

Allergy Alert (Denmark): Nordisk Kellogg ApS recalls Kellogg’s Rice Krispies (375g; Best before 17/05/20) due to lack of Danish labeling and undeclared barley.

Allergy Alert (Italy): Natura’ Srl recalls VIVIBIO MIGLIO DECORTICATO SOFFIATO (100g; various lot codes and Best before dates) due to undeclared gluten, soy, sesame and nuts.

Allergy Alert (Italy): Coop Italia Soc. Coop. recalls Benesì COOP brand Plum Cake preparato con yogurt – senza glutine / Gluten-free plum cake made with yogurt (6 pieces / 216g; Lot #CL164P; Best before 11-10-2019) due to undeclared gluten.

Allergy Alert (UK – Wales specific): Tan Y Castell recalls Tan Y Castell Chocolate Chip Griddles (6 cakes/pkg; Batch code 5060001830018; Best before 7 July 2019, 13 July 2019, 21 July 2019, 24 July 2019, 29 July 2019, 4 August 2019, 11 August 2019, 17 August 2019) due to undeclared milk.

Allergy Alert (UK – England specific): Flames Foods recalls various types of frozen products due to undeclared or inadequately declared mustard, nuts (almond), sesame, soya, egg, wheat (gluten), milk or milk constituents, sulphur dioxide and/or sulphites. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Denmark): Rokkedahl Food ApS recalls Free-range Whole Chicken from De Danske Familie Gårde (1200-1600g; Lot #23-07-19; Last day of use 03-09-19) due to incorrect date marking.

Food Safety Recall (France): Les Fumoirs de Saintonge recalls Maison Peneau brand Truite fumée de France / Smoked trout from France (250g; All lots; All Best before dates) and Maison Peneau brand Saumon fumé au sel de l’Ile de Ré / Smoked salmon with sea salt from Ile de Ré (120g; All lots; All Best before dates) due to Listeria monocytogenes contamination.

Food Safety Recall (France): La société Bioporc recalls Bonjour Campagne brand Demi Jambonneau BIO / Organic half-ham (300g; Lots J168 – 24/07/19,  J170 – 26/07/19, J171 – 27/07/19, J172 – 28/07/19, J175 – 31/07/19, J176 – 01/08/19, J179 – 04/08/19, J182 – 07/08/19, J183 – 08/08/19, J184 – 09/08/19, J191 – 16/08/19) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): t’Dischhof recalls Petit Fleur organic raw milk cheese (block and 360g; Lot #24.5; Best before 14.08.2019) due to shigatoxin-producing E. coli contamination.

Food Safety Recall (Germany): Delizza GmbH recalls Trader Joe’s Röstzwiebeln / Trader Joe’s Roasted Onions (200g; Best before 20.05.2020 to 22.05.2020) due to foreign matter (metal) contamination.

Food Safety Recall (Ireland): BWG Foods recalls SPAR Water Still Sport (750ml; Batch code 177) and  Londis Water Still (1 litre; Batch code 177) due to elevated arsenic levels.

Pet Food Safety Recall (Belgium): Flamingo Pet Products SA recalls specific batches and package sizes of Mélanges de graines pour lapins / Mixed grains rabbit food due to excessive levels of vitamin D3. Please refer to the recall notice for a complete list of affected batch codes and packaging.

Australia and New Zealand

Food Safety Recall (Australia): Gippsland Jersey recalls Gippsland Jersey Full Cream Milk (2L; Batch 1907033; Use by 29/07/2019) and Gippsland Jersey Light Milk (2L; Batch 1907034 Use by 29/07/2019) due to a processing failure associated with pasteurization.