Tag: vitamin D

Recalls and Alerts: January 14 – 16, 2021

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

Consent Decree: The U.S. District Court for the Eastern District of Washington entered a consent decree between the FDA and Valley Processing, Inc. of Sunnyside, Washington, along with the company’s owner and president, Mary Ann Bliesner, to stop distributing adulterated juice products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the consent decree. In a complaint filed on behalf of the FDA on Nov. 6, 2020, the agency stated that Valley Processing, Inc.’s juice products contained inorganic arsenic and patulin toxins at levels that can pose health risks to consumers. In addition, during an inspection by the FDA, investigators observed that the defendants processed juice under grossly insanitary conditions and failed to adhere to relevant food safety standards.

Allergy Alert: FSIS alerts the public to the presence of undeclared allergens in three brands of beef jerky products. Please refer to the FSIS alert for a complete list of affected products.

Food Safety Recall: Nestlé Prepared Foods recalls Nestlé HOT POCKETS BRAND SANDWICHES: PREMIUM PEPPERONI MADE WITH PORK, CHICKEN & BEEF PIZZA GARLIC BUTTERY CRUST (54-oz 12-pack; Lot codes 0318544624, 0319544614, 0320544614, and 0321544614; Best before FEB 2022) due to possible foreign matter (pieces of glass and hard plastic) contamination.

Food Safety Recall: Lake Champlain Chocolates recalls select LCC milk chocolate products from a determined best-by date range due to potential foreign matter (brittle plastic pieces) contamination. Please refer to the recall notice for a complete list of affected products.

Canada

Allergy Alert: Farm Boy Company Inc. recalls Farm Boy brand Marinated Teriyaki Chicken (450g; Best Before 20210128; UPC 8 08912 01858 4) due to undeclared milk.

Allergy Alert: Industry recalls Wang Korea brand sweet rice pancake products due to undeclared egg. Please refer to the recall notice for a complete list of affected products.

Allergy Alert Update: Dolson Marketing Inc. recalls Chocolate Non-Dairy Whip Topping (1 kg; UPC 6 953942 240178; All codes where “non-dairy” is declared on the label) and Orange Non-Dairy Whip Topping (1 kg; UPC 6 953942 240093; All codes where milk is not declared on the label) due to undeclared milk.

Allergy Alert: Hwa Joo Dang Enterprises Ltd. recalls HJD brand Sprouted Multi Grain (1.82 kg; UPC 6 27843 08862 2; All codes where “gluten free” is declared on the label) due to undeclared barley (gluten).

Allergy Alert: 2007064 Ontario Inc. (O/A Kokkadens) recalls Kokkadens Cakes & Bakes brand Dates & Walnut Cake (400g; UPC 9 780201 591279; All packages where egg is not declared on the label) and Kokkadens Cakes & Bakes brand Carrot & Dates Cake (400g; UPC 9 780201 379624; All packages where egg is not declared on the label) due to undeclared egg.

Food Safety Recall: Harvest Meats recalls Harvest brand Polish Sausages (675g; BEST BEFORE 2021MR15; UPC 0 57393 70017 8) due to undercooking.

Food Safety Recall: Le marché d’Emma recalls various products packed in glass jars due to improper production and packing that could render the products unsafe to consume. Please refer to the recall notice for a list of affected products.

Food Safety Recall: Just Pressed recalls various soups that are not labeled with the mandatory “keep refrigerated” instruction. Please refer to the recall notice for a list of affected products.

Food Safety Recall: La Fabrique à saucisse recalls Peperette sausages (spicy and mild) due to improper production and packing that could render the products unsafe to consume. Please refer to the recall notice for details on the affected products.

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Europe

Allergy Alert (Belgium): Industry recalls Ciloglu brand Findikli Dut Pestili / Dried fruit and nut confectionery (300g; Lot #8697436552788; Expiration date 12.02.2021 – 20.04.21 – 01.07.21 – 14.08.21 – 07.10.21 – 07.11.21) due to undeclared peanuts.

Allergy Alert (France): Auchan recalls Auchan Bio brand Sucre de fleur de coco / Coconut blossom sugar (250g; Lot #51080; Expiration date 17/10/2021) due to undeclared sulphites.

Allergy Alert (Italy): Taz Group SrL recalls Arachidi al Wasabi / Wasabi peanuts (50g; Lots 0261, 0291, 0321, 0351; Best before 01/04/2021, 01/05/2021, 01/06/2021) due to undeclared mustard.

Allergy Alert (UK): Caterers Choice Ltd recalls two Pasta Del Vallo products due to undeclared soy. Please refer to the recall notice for complete details on the affected products.

Food Safety Recall (Austria): Milupa recalls various Milupa Kindermüsli Früchte / Milupa Kindermüsli Bircher / Milupa Kinder-Porridge Hafer & Früchte baby cereals due to a choking hazard (pieces of apple stalks). Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Finland): Kieku Oy recalls Kieku, Pirkka and Kotimaista brand LK-free L4 eggs (Lots #002 & #004; Best before 5.2 and 12.2, respectively; Producer code 2FI15464) due to potential Salmonella contamination.

Food Safety Recall (Germany): Milupa recalls certain Milupa brand baby cereals due to a choking hazard (pieces of apple stalks). Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Ireland): Nutricia recalls Cow & Gate and Aptamil Muesli products due to a choking hazard (some packs have been found to contain pieces of apple stalks). Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Ireland): Tesco Ireland recalls Tesco Finest Taleggio PDO Italian Cheese ((200g; Use by 25 January 2021; Product of Italy) due to Listeria monocytogenes contamination.

Food Safety Recall (Italy): Agricola Tre Valli Soc. Coop recalls KEBAB DI POLLO CONAD (350g; Lot #8574274; Best before 22-01-2021) due to foreign matter (plastic pieces) contamination.

Food Safety Recall (Italy): Agricola Tre Valli Soc. Coop recalls AIA brand KES’S KEBAB DI POLLO (350g; Lot #8574274; Best before 22-01-2021) due to foreign matter (plastic pieces) contamination.

Food Safety Recall (Italy): Arc en Ciel Soc. Agr. Coop recalls CARREFOUR BIO brand Sugo alle verdure biologico / Organic vegetable sauce (350g; Best before 26.10.2022) due to foreign matter (glass particles) contamination.

Food Safety Recall (UK): Tesco recalls Tesco Finest Taleggio (200g; Use by 25 January 2021) due to Listeria monocytogenes contamination.

Food Safety Recall (UK): Nutricia recalls Cow & Gate and Aptamil Muesli products due to a choking hazard (some packs have been found to contain pieces of apple stalks). Please refer to the recall notice for a complete list of affected products.

Pet Food Safety Recall (Austria): Mars Austria recalls PEDIGREE Adult with Chicken & Vegetables dry dog ​​food (15kg & 3kg; various Best before dates) due to high levels of vitamin D. Please refer to the recall notice for specifics on lot codes and Best Before dates.

Pet Food Safety Recall (Belgium): Mars Belgium recalls several dog food products due to high levels of Vitamin D. Please refer to the recall notice for a complete list of affected products.

Pet Food Safety Recall (UK): Mars Petcare UK recalls several dog food products due to high levels of Vitamin D. Please refer to the recall notice for a complete list of affected products.

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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.