Category Archives: FDA

USA – FDA CORE Response Team Update

FDA

A new Salmonella Miami outbreak has been announced by the FDA in their CORE Table. The only information given is that 48 people are sick.   

Research – An Outbreak Investigation of Scombrotoxin Fish Poisoning Illnesses in the United States Linked to Yellowfin Tuna Imported from Vietnam – 2019

Journal of Food Protection

Scombrotoxin fish poisoning (SFP) is caused by the ingestion of certain fish species with elevated levels of histamine due to decomposition. In the fall of 2019, the Food and Drug Administration (FDA) was notified of 51 SFP illnesses including two hospitalizations from 11 states through consumer complaints received by FDA’s Consumer Complaint System or directly from state partners. A case was defined as an individual who experienced a histamine-type reaction after consumption of tuna imported from Vietnam and an illness onset between August 14, 2019 and November 24, 2019. A traceback investigation was initiated at 19 points-of-service (POS) to identify a common tuna source. FDA and state partners collected a total of 34 product samples throughout the distribution chain including from a case patient’s home, POS, distributors, or at the port of entry. Samples were analyzed by sensory evaluation and/or chemical testing for the presence of histamine. Cases reported exposure to tuna imported from Vietnam. The traceback investigation identified two Vietnamese firms as the sources of the tuna. Twenty-nine samples were confirmed as decomposed by sensory evaluation and/or positive for the presence of elevated levels of histamine by chemical testing. Both Vietnamese firms were placed on Import Alert. Seven U.S. firms and one Vietnamese firm initiated voluntary recalls. FDA released public communication naming the U.S. importers to help suppliers and distributors to identify the product and as a result, effectuate the foreign firm’s recall. This SFP outbreak investigation highlights the complexities of the federal outbreak response, specifically related to imported food. Imported foods present cultural considerations that need to be addressed during outbreak response when timing is critical. Furthermore, collaborating with countries where confidentiality agreements are not in place can limit information sharing and the speed of public health response efforts.

USA – Midwestern Pet Foods Voluntarily Expands Recall of Pet Food for Aflatoxin Health Risk

FDA

Midwestern Pet Foods, Inc., of Evansville, IN is expanding its December 30, 2020 voluntary recall of certain dog and cat food products produced in our Chickasha Operations Facility to include all dog and cat pet food products made with corn products because those products may contain aflatoxin levels which exceed acceptable limits. Products were distributed nationally to online distributors and retail stores nationwide. Midwestern Pet Foods is expanding its voluntary recall out of an abundance of caution to help protect the health and safety of pets. The products recalled cover all that expire on or before July 9, 2022, depicted as “07/09/22” in the date code on the product, as discussed below. Products with expiration dates after 07/09/22 are not included in the recall.

Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.

There have been reports of illnesses and deaths in dogs associated with certain lots of products. No human illnesses have been reported. Out of an abundance of caution, we have expanded this recall to cover all corn products containing pet foods with expiration dates prior to 07/09/22.

If your pet shows signs of aflatoxin poisoning including sluggishness, loss of appetite, vomiting jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea, contact a veterinarian immediately. Provide a full diet history to your veterinarian. It may be helpful to take a picture of the pet food label, including the lot number and best buy date.

Lot code information may be found on the back of bag and will appear in a three‐line code, with the top line in format “EXP 03/03/22/05/L#/B###/HH:MM”.

As explained above, this recall covers ONLY product manufactured at Midwestern Pet Food’s Chickasha, Oklahoma facility. Note that the unique Chickasha Facility identifier is located in the date code as a
“05” and “REG. OK‐PFO‐0005” at the end of the date code.

In addition, the only Midwestern Pet Foods facility that produces product bearing a three‐line date code is our Chickasha Facility (See first image below).

Retailers and distributors should immediately pull recalled lots from their inventory and shelves. Do not sell or donate the recalled products. Retailers are encouraged to contact consumers who have purchased the recalled products, if you have the means to do so (frequent buyer cards, etc.).

Pet parents: do not feed the recalled products to your pets or any other animals. Destroy the food in a way that children, pets and wildlife cannot access them. Wash and sanitize pet food bowls, cups, and storage containers. Always ensure you wash and sanitize hands after handling recalled food or any utensils which have contacted recalled food. Contact Midwestern Pet Foods Consumer Affairs at 800‐474‐4163, ext. 455 from 7AM to 4PM Central Time, Monday through Friday, or by email at info@midwesternpetfoods.com for additional information.

This voluntary recall is being conducted in cooperation with the U.S. Food and Drug Administration. All other Midwestern Pet Foods products are unaffected by this recall action.

Recalled products are as follows, with lot codes found in Expanded Recall Lot Numbers:

  • Pro Pac Adult Mini Chunk
  • Pro Pac Performance Puppy
  • Splash Fat Cat 32%
  • Nunn Better Maintenance
  • Sportstrail 50
  • Sportmix Original Cat 15
  • Sportmix Original Cat 31
  • Sportmix Maintenance 44
  • Sportmix Maintenance 50
  • Sportmix High Protein 50
  • Sportmix Energy Plus 44
  • Sportmix Energy Plus 50
  • Sportmix Stamina 44
  • Sportmix Stamina 50
  • Sportmix Bite Size 40
  • Sportmix Bite Size 44
  • Sportmix High Energy 44
  • Sportmix High Energy 50
  • Sportmix Premium Puppy 16.5
  • Sportmix Premium Puppy 33

Original Press Release


Company Contact Information

Consumers:
Midwestern Pet Foods Consumer Affairs
 800‐474‐4163, ext. 455
 info@midwesternpetfoods.com

USA – Lavva Voluntarily Recalls a Single Lot of Blueberry Plant-Based Yogurt – Mold

FDA

Recall Limited to Lavva Blueberry Plant-Based Yogurt 5.3 Ounce Dated 2/21/21

Out of an abundance of caution, EVR Foods, INC, parent company to Lavva, is issuing a voluntary recall on its 5.3 ounce Blueberry Plant-Based Yogurt with expiration date 2/21/21. While this SKU and date code cleared strict quality assurance protocols, recent testing indicates a potential mold contamination. No other Lavva products are affected by the recall.

This plant-based yogurt was produced at a manufacturing facility in Norwich, NY, and has only been linked to the single date code. There have been no confirmed illnesses to date.

The recalled Blueberry Plant-Based Yogurts were distributed to retail stores nationwide. The product comes in a 5.3 ounce, colorful plastic cup with a foil lid, marked with lot #022121 on the bottom of the cup which is also used as the expiration date of the product.

Consumers are urged not to eat the product subject to the recall. Anyone who purchased the SKU may return it to the place of purchase for a full refund. Consumers with questions about the recall can reach out to hello@lovvelavva.com or 833-885-2882 between 9 a.m. to 5 p.m. EST Monday through Friday. The Food & Drug Administration (FDA) has been notified of this recall and is assisting with the process.

About Lavva

Founded in 2017, Lavva is on a mission to realize the full potential of plant-based foods made without compromise. Powered by the world’s lowest carb, highest fat nut called the pili, Lavva’s functional superfoods are minimally processed and made only with real food ingredients — no added sugar, gums, oils, or natural flavors. Founder and CEO Liz Fisher discovered pili nuts while following a strict keto diet during a successful battle with advanced-stage ovarian cancer. Blown away by the pili’s smooth, buttery flavor Liz began blending them with coconut milk and eventually perfected the recipe to become what we know as Lavva’s yogurt today. Lavva currently offers its flagship Lavva yogurt line in six flavors — including two in 16-ounce family sizes — such as Vanilla, Mango, and Strawberry and the market’s first keto-certified vegan yogurt, Molten Lavva. Additionally, Lavva launched its Plant Milks and Creamer in September 2020, bringing a more sustainable alternative to the non-dairy milk category thanks to wild harvested pili trees. The brand is available at retailers nationwide, including Whole Foods Market, Sprouts, Kroger, and local natural food stores. All of Lavva’s products are vegan, dairy free, and use organic ingredients whenever possible.


Company Contact Information

Consumers:
Lavva
 33-885-2882
 hello@lovvelavva.com

Product Photos

USA – Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)

FDA

The FDA and CDC, in collaboration with state and local partners, have completed the investigation on two of three multistate outbreak of E. coli O157:H7 infections in the U.S. this fall.

One of these investigations, Outbreak Unknown Source 3, identified 18 reported illnesses in nine states: California, Colorado, Illinois, Michigan, New York, Ohio, Pennsylvania, Virginia, Washington.

FDA completed a traceback investigation of several potential food vehicles identified in patient interviews and although no single farm was identified as a common source of the outbreak, FDA and state partners also conducted on-site investigations on farms of interest. However, information and samples collected in these inspections did not link these farms to the outbreak. The investigation of a farm does not mean that the farm is linked to an outbreak. The results of an investigation into a farm may well lead to that firm being ruled out of the investigation. On 12/18/2020, the CDC announced that this outbreak had ended.

The other completed outbreak investigation, Outbreak Unknown Source 1, identified 32 reported illnesses in 12 states: California, Illinois, Louisiana, Maryland, Michigan, Montana, New Jersey, Ohio, Utah, Virginia, Washington, Wisconsin. This strain of E. coli is genetically similar to a strain linked to a romaine outbreak that occurred in the spring of 2018, though a food was not linked to the current outbreak. FDA completed a traceback investigation and was unable to determine a common source of the outbreak. FDA and state partners also conducted on-site inspections on farms of interest, though information collected in these inspections did not link these farms to the outbreak. On 12/18/2020, the CDC announced that this outbreak had ended.

Investigations of a third E. coli outbreak of Unknown Source 2 continue.

Recommendation

Consumers, restaurants, and retailers, were advised not to eat, sell, or serve recalled Tanimura & Antle, Inc. brand packaged single head romaine lettuce with a pack date of 10/15/2020 or 10/16/2020.

The recalled products are now well beyond expiration and likely no longer on the market or in consumers’ homes.

USA – FDA CORE Outbreak Investigation Table Updated

FDA

The link above has a list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.

public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.

Outbreaks of Foodborne Illness

Note: Not all recalls and alerts result in an outbreak of foodborne illness. Check recent Food Recalls and Safety Alerts.

Outbreak investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. If a source and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

USA – Hy-Vee Voluntarily Recalls Two Short Cuts Vegetable Mix Products Because of Possible Health Risk – Listeria monocytogenes

FDA

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two of its Hy-Vee Short Cuts vegetable mix products across its eight-state region (IL, IA, KS, MN, MO, NE, SD, and WI) due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered during routine safety sampling at Hy-Vee’s Short Cuts production facility. To date, no illnesses have been reported in connection with these products.

Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

Out of an abundance of caution, Hy-Vee is recalling the following products from all of its stores:

  • Hy-Vee Short Cuts Pot Roast Mix – UPC Code 0272083305352
  • Hy-Vee Short Cuts Grill/Oven Ready Veggie Mix – UPC Code 0272104105992

All affected products have a “Best if Used By” date of Dec. 3, 2020. Photos of the affected product labels are attached. No other Hy-Vee Short Cuts products or products used in Hy-Vee stores are affected by this recall.

Customers who purchased any of these products with these dates should not consume them. Customers are being asked to discard these items or return them to their local Hy-Vee store for a full refund.

Consumers with questions may contact Hy-Vee Customer Care representatives 24 hours a day, seven days a week at (800) 772-4098.

Hy-Vee, Inc. is an employee-owned corporation operating more than 275 retail stores across eight Midwestern states with sales of $11 billion annually. The supermarket chain is synonymous with quality, variety, convenience, healthy lifestyles, culinary expertise and superior customer service. Hy-Vee ranks in the Top 10 Most Trusted Brands and has been named one of America’s Top 5 favorite grocery stores. The company’s more than 85,000 employees provide “A Helpful Smile in Every Aisle” to customers every day. For additional information, visit www.hy-vee.com.External Link Disclaimer


Company Contact Information

Consumers:
Hy-Vee Customer Care
 (800) 772-4098
Media:
Dawn Buzynski
 (515) 695-3090
 dbuzynski@hy-vee.com

Product Photos

USA – Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts – STEC E.coli

FDA

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of organic romaine hearts. The products being recalled are Dole™ Organic Romaine Hearts 3pk (UPC 0-71430-90061-1), combined English/French packaging, with Harvested-On dates of 10-23-20 and 10-26-20, and Wild Harvest Organic Romaine Hearts (UPC 7-11535-50201-2), with Harvested-On dates of 10-23-20 and 10-26-20.  The recall is being conducted due to a possible health risk from E. coli in the two products.  Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported to date in association with the recall.

Pathogenic E. coli can cause diarrhea, severe stomach cramps and vomiting.  Most people recover within a week, but some illnesses can last longer and can be more severe.

The Harvested-On sticker is located on the upper right corner of each bag and the UPC code is located on the bottom right corner of the back of each bag. The Dole package contains three organic romaine hearts and the Wild Harvest product is packaged in a 12oz bag. The impacted products were distributed in AZ, HI, IA, IL, IN, KS, MD, MI, MN, MO, MS, MT, NC, ND and VA. These products were harvested and packed nearly 4 weeks ago and should no longer be in commerce.  Consumers are advised to check product they have in their homes and discard any product matching the production description, UPC codes and Harvested-On dates listed above.

This precautionary recall notification is being issued due to an isolated instance in which a package of Dole™ Organic Romaine Hearts – 3pk yielded a positive result for pathogenic non-O157 E.coli STEC in a routine sample collected at a retail store by the Michigan Department of Agriculture and Rural Development. There is no indication at this time that this positive result is related to any illnesses nor consumer complaints and it is not associated with the strains connected to the ongoing outbreaks currently under regulatory investigation.

No other Dole products are included in the recall. This voluntary recall does not apply to any bagged or clamshell salad romaine product. Only the specific Organic Romaine Hearts listed, with the exact UPC codes and Harvested-On dates identified above, are included in the recall. Consumers who have any remaining product with these UPC codes and Harvested-On dates should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Consumer Center at 1-800-356-3111, which is open 24 hours a day.


Company Contact Information

Consumers:
Consumer Center
 1-800-356-3111
Media:
William Goldfield
 1-818-874-4853
 William.Goldfield@Dole.com

Product Photos

USA – FDA – Investigations of Foodborne Illness Outbreaks

FDA

The following is a list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.

public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.

USA – Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)

FDA

The FDA and CDC, in collaboration with state and local partners, is investigating illnesses in a third multistate outbreak of E.coli O157:H7 infections this Fall.

On November 6, 2020, the Michigan Department of Agriculture and Rural Development (MDARD) reported that as a part of routine sampling, they collected a product sample of romaine lettuce for testing. The sample tested positive for E. coli O157:H7 and subsequent whole genome sequencing (WGS) analysis determined that the E. coli O157:H7 present in the samples matches the strain that has caused illnesses in this outbreak.

The strain of E. coli found in the Michigan sample is a third distinct strain not genetically related to the strains causing two distinct multi-state outbreaks of Shiga-toxin producing E. coli O157:H7 (STEC) that FDA and CDC announced on October 28, 2020. At this time, a specific food has not been linked to either of those outbreaks.

On November 6, 2020, Tanimura & Antle, Inc. recalled packaged single head romaine lettuce with a pack date of 10/15/2020 or 10/16/2020 due to possible contamination with E. coli O157:H7. The firm recalled this product based on test results from a product sample collected and analyzed by MDARD before the WGS analysis showing the match to the outbreak strain was completed.

FDA and state partners are working with the firm to determine if additional romaine should be recalled.

At this time, there is not enough epidemiologic and traceback evidence to determine if ill people in this outbreak were exposed to romaine lettuce from Tanimura & Antle, Inc. Additional information will be provided as it becomes available.

Recommendation

Consumers, restaurants, and retailers, should not eat, sell, or serve Tanimura & Antle, Inc. brand packaged single head romaine lettuce with a pack date of 10/15/2020 or 10/16/2020.