Recalls and Alerts: December 8 – 12, 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: CDC, FDA and the Pennsylvania Department of Health report 11 confirmed cases of Salmonella Javiana illness associated with consumption of Tailor Cut Produce Fruit Mix in Pennsylvania and Minnesota. At least 20 additional cases are under investigation. See below for a link to the product recall.

OUTBREAK ALERT: CDC, FDA and their Canadian counterparts are investigating a cross-border outbreak of E. coli O157:H7 illnesses linked to Fresh Express Sunflower Crisp Chopped Salad Kits. Eight confirmed illnesses have been reported from 3 US states. Please see below for a link to the product recalls.

Food Safety Recall: CATSMO LLC recalls Cold Smoked Salmon (various package sizes, cuts, and expiration dates) due to potential Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Ruiz Food Products Inc. recalls EL MONTEREY Signature BURRITO EGG, SAUSAGE & CHEESE, frozen, NRTE (3.38-lb. Value Pack, containing 12 individually wrapped, 4.5-oz. burritos; Lot #19288; Best if used by 01/15/2021) due to possible foreign matter (pieces of plastic) contamination.

Food Safety Recall: Tailor Cut Produce recalls Fruit luau, cut honeydew, cut cantaloupe and cut pineapple products (2/1 gallon cases; Production dates November 15 – December 1, 2019) due to possible Salmonella contamination. See OUTBREAK ALERT, above, for additional information.

Canada

OUTBREAK ALERT: PHAC and CFIA are investigating an outbreak of 24 confirmed cases of E. coli O157:H7 illnesses in Ontario (11), Quebec (3), New Brunswick (4), Nova Scotia (4), Prince Edward Island (1), and Newfoundland and Labrador (1). The outbreak has been linked to consumption of Fresh Express brand Sunflower Crisp Chopped Salad Kits. Additional outbreak cases have been reported in the USA (see link, above). Please also see below for a link to the product recall.

OUTBREAK ALERT: PHAC is investigating an outbreak of 92 Salmonella Typhimurium illnesses across Canada linked to contact with pet snakes, pet rodents and feeder rodents. Illnesses have been reported from British Columbia (4), Ontario (16), Quebec (52), New Brunswick (9), Nova Scotia (5) and Newfoundland and Labrador (6).

Allergy Alert: Sobeys Inc. recalls Pete’s Fine Foods brand Large Cranberry Vanilla Cardamom Granola (500g; Best Before: 2020.JA.20; UPC 0 202638 212996) and Pete’s Fine Foods brand Small Cranberry Vanilla Cardamom Granola (85g; Best Before: 2020.JA.20; UPC 0 202631 702500) due to undeclared pecans.

Food Safety Recall: Industry recalls Fresh Express brand Sunflower Crisp Chopped Kit (315g; All packages bearing a Best Before dates up to and including 07DE19, and a lot code beginning with “Z”, and indicating “Salinas” as a source of Romaine lettuce) due to E. coli O157:H7 contamination. This product has been linked to an outbreak (see above).

Food Safety Recall: Loblaw Companies Limited recalls PC brand Cranberry Goat’s Milk Cheese (300g; Best before 2020 MR 19 & 2020 MR 24; UPC 0 60383 01013 3) due to foreign matter (pieces of plastic) contamination.

Food Safety Recall: Rejuice! recalls various soups due to improper storage temperature and absence of label instruction regarding correct storage. Please refer to the recall notice for a complete list of affected products.

Europe

Allergy Alert (Belgium): Colruyt recalls SAUCE FINE CHAMPAGNE (500g; Best before 9/01/2020) due to undeclared wheat (gluten) and soy.

Allergy Alert (Belgium): Mora recalls Mora brand Burgers de poulet / chicken burgers (4X70g; Lots L9246, L9288 & L9289; Best before 09-2020 & 10-2020) due to undeclared milk.

Allergy Alert (Belgium): Boerinneke recalls Boerinneke brand pâte à tartiner bio Noir (400g; Lot 8262; Best before 19/12/2019) due to undeclared milk and soy.

Allergy Alert (Belgium): Boerinneke recalls various spreads due to undeclared nuts. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (Belgium): Zuger recalls Ambachtelijke choco Zuger / Artisanal chocolate (250g; All “Best before” dates between 09/12/2019 and 09/05/2020) due to undeclared soy and milk.

Allergy Alert (Belgium): VAJRA recalls VAJRA brand gluten powder (400g; Lot #0219/141119; Best before 20.07.21) due to undeclared mustard.

Allergy Alert (France): Industry recalls Abbot Kinney’s brand Coco Frost Cacao (various sizes and batch codes) due to undeclared gluten. Please refer to the recall notice for a complete list of affected batch codes.

Allergy Alert (Ireland): Hipp UK Ltd. recalls Hipp Organic Combiotic First Infant Milk Starter Pack (6x90ml: Batch codes L-099191, L-162192, L-186191; Best before 09 January 2020, 11 March 2020, 5 April 2020) due to undeclared fish oil.

Allergy Alert (Luxembourg): Delhaize recalls Boerinneke brand Pâte à tartiner aux noisettes 13% (200g & 400g; All lot codes and Best before dates) due to undeclared nuts.

Allergy Alert (Luxembourg): Colruyt recalls SAUCE FINE CHAMPAGNE (500g; Best before 9/01/2020) due to undeclared wheat (gluten) and soy.

Allergy Alert (Netherlands): Mora recalls Mora brand Burgers de poulet / chicken burgers (4X70g; Lots L9246, L9288 & L9289; Best before 09-2020 & 10-2020) due to undeclared milk.

Allergy Alert (UK): Hipp UK recalls Hipp Organic Combiotic First Infant Milk Starter Pack (6x90ml: Batch codes L-099191, L-162192, L-186191; Best before 09 January 2020, 11 March 2020, 5 April 2020) due to undeclared fish oil.

Allergy Alert (UK): Sainsbury’s recalls by Sainsbury’s 18 Mini Egg Bites (186g; Use by 17th December) due to undeclared egg and mustard.

Food Safety Recall (Belgium): ALDI recalls Excellence brand Rôti de dinde farci aux pommes et raisins secs (surgelé) / Roast turkey stuffed with apples and raisins, frozen (800g; Lots 410933, 410377, 410925; Use by 30/01/2021) due to Salmonella contamination.

Food Safety Recall (Denmark): Dagrofa recalls Gestus Madsalat med Solsikkekerner og Hasselnødder / Gestus salad with sunflower seeds and hazelnuts (500g; Best before 11/12-2019) due to Listeria monocytogenes contamination.

Food Safety Recall (Italy): Società Agricola Locatelli Guglielmo & C. S.S. recalls Stracchino all’antica (Lot code 12/10/2019 – 41a Settimana) due to shigatoxin-producing E. coli contamination.

Food Safety Recall (Luxembourg): ALDI recalls Excellence brand Rôti de dinde farci aux pommes et raisins secs (surgelé) / Roast turkey stuffed with apples and raisins, frozen (800g; Lots 410933, 410377, 410925; Use by 30/01/2021) due to Salmonella contamination.

Australia and New Zealand

Allergy Alert (New Zealand): Food Hub Pakuranga Ltd recalls Guangxiang brand Pork Won Ton and Vege Pork Won Ton (all batches and dates of both products) due to undeclared gluten (wheat), sesame and soy.

Food Safety Recall (New Zealand): Neat Meat Global Ltd recalls Harmony Free-Range Boneless Ham (1 to 3.5kg; Use by 27/1/2020, 28/1/2020, 29/1/2020, 30/1/2020) and Harmony Free-Range Champagne Ham (4 to 5 kg; Use by 30/1/2020, 31/1/2020) due to possible Listeria monocytogenes contamination.

Food Safety Recall (New Zealand): Tegel Foods Ltd recalls Tegel brand Crumbed Chicken Burgers (1kg; Batch code 19259; Best before Sep 2020) due to foreign matter (small pieces of metal wire) contamination.

Food Safety Recall (New Zealand): Lion recalls Lindauer brand Fraise (Lindauer & strawberry) (200ml x 4 pack; Batch codes L9164 PW374 20:27 to 20:39 & L9165 PW374 07:41 to 07:58) due to possible foreign matter (pieces of glass) contamination.

Valley Proteins receives FDA Warning Letter one year after pentobarbital found

Valley Proteins, Inc., a renderer located in Winchester, Virginia, was issued a Warning Letter from the US Food and Drug Administration (FDA) on November 18, 2019, one year almost to the day after FDA found pentobarbital in a sample of the company’s “animal fat product.”

The Warning Letter cited several violations of the Federal Food, Drug and Cosmetic Act revealed during the course of FDA inspections carried out in February 2019 and April 2019.

The animal fat product was adulterated due to the presence of pentobarbital

According to the Warning Letter, FDA advised Valley Proteins on December 18, 2018 that the agency had found pentobarbital in a sample of the Company’s animal fat product.

Despite the requirements spelled out in the Company’s formal Recall Plan, Valley Proteins “…did not take immediate action to notify customers or recall the product…”

On four separate occasions in February and in April 2019, FDA inquired as to whether the Company planned to recall the contaminated product. Valley Proteins declined to initiate a recall and refused to supply FDA with requested information regarding the amount of potentially affected product that was distributed by the Company before it learned of the pentobarbital contamination.

In response to FDA’s finding, Valley Proteins asserted that pentobarbital is an “unavoidable contaminant not known to present a health hazard,” an assertion strongly refuted by FDA in its Warning Letter, which included the following statement:

“Adulteration of animal food with pentobarbital is not unavoidable. It is your responsibility to prevent adulteration of animal food with unsafe new animal drugs by ensuring that you are not receiving ingredients from your suppliers that contain unsafe new animal drugs or by developing methods to ensure that materials you receive containing unsafe new animal drugs are segregated and not used for animal food.”

The animal fat product was adulterated due to Animal Food Hazard Analysis and Risk-Based Preventive Controls (PC) violations

Specifically, Valley Proteins did not “…identify and evaluate hazards that may be specific to the source of [the] raw material, which included carcasses of animals euthanized with pentobarbital” in that the Company’s Hazard Analysis “…did not list Pentobarbital as a known and reasonably foreseeable hazard.”

Valley Proteins began cleaning operations and started testing for pentobarbital in January 2019. However, it did not provide FDA with any indications as to how it planned to account for adulterated product that was distributed prior to starting its cleaning and testing program.

In fact, the Company continues to assert that it has no legal requirement to recall any products due to pentobarbital contamination.

In an update to its Hazard Analysis documentation, the Company states that it will no longer accept or process “dead stock” (i.e., euthanized animals). However, in a letter to its customers, the Company indicates that it “…will accept euthanized animals for collection and disposal, but chemically euthanized animals will not be rendered.”

FDA has requested, but has not yet received, information as to how Valley Proteins proposes to collect and dispose of euthanized animals.

Microbial hazards

FDA also highlighted concerns regarding the Company’s process control to prevent microbial hazards.

Specifically,
1. Bills of Lading for some products should have – but did not – including the statement, “not processed to control microbial hazards.”
2. The Company’s process controls lacked adequate parameters for controlling some microbial hazards, including Salmonella, E. coli and Listeria monocytogenes.
3. The process control parameters provided to FDA by the Company did not match the parameters as determined in the scientific study presented to validate those process controls.

Where did the adulterated animal fat go?

According to a spokesperson for FDA, the Company claims that none of the adulterated animal fat was distributed to pet food manufacturers. However, the firm did not provide any documentation to support its assertion.

The Warning Letter describes the adulterated sample as having been taken from a finished fat tank “…used to store animal fat distributed for use in animal food.” This could refer to food for livestock, including poultry, cattle, etc.

FDA is at risk of becoming a paper tiger

Setting aside the specific violations cited in this Warning Letter, Valley Proteins is just the latest in a string of companies that has refused an FDA request for a product recall, for documentation, or for some other aspect of cooperation in an investigation.

In recent months, we have seen at least two other instances of non-cooperation, even in the face of a direct risk to the health of consumers or their companion animals.

Lystn, LLC (Answers Pet Food) initiated a lawsuit against FDA, the US Department of Health and Human Services, and the Colorado Department of Agriculture, among others, rather than agree to a recall of its contaminated raw pet food products.
FDA was forced to take the extreme step of suspending facility registration of Topway Enterprises Inc. (a Texas-based seafood producer), citing “…an unwillingness and disregard by the company to cease operations and correct severe violations at their facility.”

These two examples are only the tip of the iceberg. It is not uncommon for company officials to decline FDA inspectors access to consumer complaint records, product formulations, and other information that inspectors often need to conduct their oversight. It is not unknown for a company to deny an inspector permission to document observations by photography, and later dispute the accuracy of the inspector’s written observations.

FDA’s remedies in the face of non-cooperation are limited. In theory, FDA is empowered under existing law to demand full access to these records. In practice, however, there is little an FDA inspector can do to enforce the agency’s authority other than by suspending the inspection and applying for a court order.

Similarly, FDA’s mandatory recall authority is a clumsy and slow instrument of last resort. The mandatory notification and appeal process would render moot an eventual mandatory recall of a perishable product. FDA’s best tool is to issue a Public Health Alert, warning consumers of the hazard posed by the offending firm’s products.

It’s time for a more assertive FDA stance

A driver caught for speeding is obliged by law to produce relevant documentation (driver license, vehicle registration and proof or insurance) upon request. Declining such a request lands the driver in even hotter water than before. Nor can the driver fight the charge by claiming that a speed limit is arbitrary and thus may be ignored.

Perhaps it’s time for FDA to arm its inspectors with the appropriate warrant or court order at the start of an inspection, especially in the case of a company with a history of prior non-cooperation.

Perhaps it’s time for an amendment to the Food Safety Modernization Act. One that will grant FDA the authority to suspend a company’s operations in the event of non-cooperation with a lawful inspection.

Recalls and Alerts: December 5 – 7, 2019

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United States

OUTBREAK ALERT: FDA and the Pennsylvania Department of Health (DOH) are investigating an outbreak of 31illnesses caused by Salmonella Javiana at four healthcare facilities in Pennsylvania. The outbreak appears to be linked to fruit mix with cantaloupe, honeydew, pineapple, and grapes prepared by Tailor Cut Produce.

Allergy Alert: Tropical Nut and Fruit Co. recalls Truly Good Foods South of the Border nut mix (25-lb box; Lot #29119; Best before 04/15/2020; UPC 094184110198) due to undeclared soy and tree nuts.

Allergy Alert: Nassau Candy Distributors recalls Nancy Adams, Dark Chocolate Graham Crackers (7.5 oz / 212g; Best if used by 4/30/20, 5/1/20, 5/21/20, 6/30/20, 8/4/20) due to undeclared milk.

Food Safety Recall: White Castle Frozen Food Division recalls multiple production lots of Frozen Cheeseburger and hamburger sliders due to Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Pet Food Safety Recall: The J. M. Smucker Company recalls Special Kitty® Mixed Grill Dinner Pate (5.5-oz can; Lot #9263803; Best if used by 9/19/2021), and three variety packs containing the impacted product due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards. Please refer to the recall notice for additional details.

Pet Food Safety Recall: Go Raw, LLC recalls Quest Beef Cat Food (2-lb bags; Lot N128; UPC 6-91730-17101-8) due to possible Salmonella contamination.

Canada

Allergy Alert: Tosuta International Sales Ltd. recalls Landers’ Australian brand Gluten free Macadamia Shortbread (175g; BEST BEFORE 23 SEP 20; UPC 6 66394 00012 7) due to undeclared milk.

Allergy Alert: Marché Kohinoor recalls various meat products due to undeclared sulphites. Please refer to the recall notice for a complete list of affected products.

Allergy Alert: Lemond Food Corp. recalls OurHome brand Spicy Jjamppongs (Frozen Noodles) (1.2 kg; All lot codes; UPC 8 809257 824238) due to undeclared oyster and squid.

Food Safety Recall: Pizzeria Morso TM Mtl Central recalls various tapinades due to lack of labelling indicating correect storage temperature. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Saucissons d’Antan recalls Pâté de foie / Liver pâté (Variable weights; Best before 2019-12-05) due to Listeria monocytogenes contamination.

Food Safety Recall: Usine Amsellem Inc. recalls Amsellem brand Solo Chorizo – Dried Beef Sausage (28g; Product code 91002DC-707 / BB 2020 AVR 08; UPC 6 28055 38930 9) due to Salmonella contamination.

Food Safety Recall: Les Importations Mini Italia Inc. recalls Golosine brand Pancetta Stagionata “Rigatino” – Dried Cured Pork Belly (900g; Lot #L11923504P; Best before 12/AL/2020) due to Listeria monocytogenes contamination.

Food Safety Recall: Low Carb Canada recalls Smart Cake brand Chocolate Smart Cake (120g; Lot 177; UPC 7 36846 00656 1) and Smart Cake brand Raspberry Cream Smart Cake (120g; Lot 177; UPC 8 53817 00825 3) due to foreign matter (metal shavings) contamination.

Europe

Allergy Alert (Austria): REWE International AG recalls SIMPLY GOOD ROTE LINSEN SUPPE MIT KOKOSMILCH / Simply Good brand Red Lentil Soup with Coconut Milk (450 mL; Lot L332; Best before 25.12.2019) due to undeclared traces of gluten and soy.

Allergy Alert (Germany): Udea B.V. recalls Abbot Kinney’s Coco Frost Kakao (500 ml; Lot L9108; Best before 17/04/2021) and Abbot Kinney’s Coco Frost Kakao (125 ml; Lots L9093 / L9094 and L9199; Best before 17/04/2021) due to undeclared gluten.

Allergy Alert (Ireland) Oumph! recalls Oumph! The Chunk (280g; Batch code 180919; Best before 18 March 2021) due to undeclared mustard.

Allergy Alert (Ireland): Unilever recalls Pot Noodle Beef & Tomato (90g; Batch code L9282; Best before July 2020) due to undeclared celery and mustard.

Allergy Alert (UK): Oumph! recalls Oumph! The Chunk (280g; Batch code 180919; Best before 18 March 2021) due to undeclared mustard.

Allergy Alert (UK): Unilever recalls Pot Noodle Beef & Tomato (90g; Batch code L9282; Best before July 2020) due to undeclared celery and mustard.

Food Safety Recall (France): Casino recalls Casino brand Céleri rémoulade (300g; Lot #933001; Best before 14/12/2019) due to potential foreign matter (pieces of blue plastic) contamination.

Food Safety Recall (Luxembourg): REWE recalls REWE Feine Welt brand Kürbis Salbei Girasoli (250g; Best before 22/12/2019; Product of Italy) due to foreign matter (metal foil) contamination.

Food Safety Recall (Luxembourg): Auchan recalls Cobolux brand Haché mélange épicé (approx. 500g; Lot #20191203; Best before 09/12/2019) due to Salmonella contamination.

Australia and New Zealand

Allergy Alert (Australia): Oldway Farm Pty Ltd recalls various deli beef products due to undeclared gluten. Please refer to the recall notice for a complete list of affected products.