Category Archives: FDA

USA – FDA Enforcement Notices Update

FDA

Enforcement Report – Week of January 20, 2021

USA – FDA’s CORE Response Team Updateed

FDA

The following is a list of outbreak 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.

USA – Lancaster Foods Recalls All Conventional Butternut Squash Items That Were Processed between the Dates of 12/22/20 and 01/08/21 Due to Possible Health Risk

FDA

Lancaster Foods LLC has initiated a voluntary product recall of its processed butternut squash items because they have the potential to be contaminated with Listeria Monocytogenes, 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 infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported to date in connection with this problem.

The recalled items were distributed in NC, VA, DC, MD, PN, NY, NJ, CT, RI, MA, NH, and VT mainly through retail stores.

The products noted:

  1. 16 oz Autumn Medley – UPC 8 13055 01115 6; with the expiration dates of 01/05/21, 01/07/21, and 01/09/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  2. 12 oz Butternut Squash Noodles – UPC 8 13055 01749 3; with the expiration date of 01/10/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamperevident clamshell.
  3. 12 oz Butternut Squash Noodles – UPC 8 13055 01864 3; with the expiration dates of 01/05/21, 01/08/21, 01/10/21, 01/11/21, 01/12/21, 01/15/21, and 01/17/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  4. 12 oz Butternut Squash Noodles – UPC 6 88267 17259 5; with the expiration dates of 01/08/21, 01/10/21, 01/12/21, 01/13/21, 01/14/21, 01/15/21, and 01/17/21 noted on the bottom scan label. The brand name is Store Brand and the package is a clear plastic tamper-evident clamshell.
  5. 21 oz Butternut Squash Planks – UPC 8 13055 01272 6; with the expiration dates of 01/02/21, 01/08/21, 01/12/21, 01/15/21, and 01/17/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  6. 20 oz Squash Noodle Medley – UPC 8 13055 01836 0; with the expiration dates of 01/05/21, 01/08/21, 01/13/21, 01/14/21, and 01/16/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  7. 20 oz Squash Noodle Medley – UPC 6 88267 18585 4; with the expiration dates of 01/03/21, 01/08/21, 01/11/21, 01/17/21, 01/18/21, and 01/19/21 noted on the bottom scan label. The brand name is Store Brand and the package is a clear plastic tamper-evident clamshell.
  8. 2.5# Butternut Squash Chunks – UPC 8 13055 01596 3; with the expiration dates of 01/04/21, 01/12/21, 01/15/21, and 01/18/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  9. 20 oz Butternut Squash Chunks – UPC 8 13055 01150 7; with the expiration dates of 01/05/21, 01/08/21, 01/09/21, 01/13/21, and 01/16/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  10. 24 oz Butternut Squash Chunks – UPC 8 13055 01300 6; with the expiration dates of 01/12/21, 01/13/21, 01/15/21 noted on the bottom scan label. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  11. 12 oz Butternut Squash Chunks – UPC 8 13055 01391 4; with the expiration dates of 01/04/21, 01/05/21, 01/07/21, 01/11/21, 01/12/21, 01/15/21, 01/17/21, and 01/20/21 noted on the bottom scan labels. The brand name is Lancaster Foods and the package is a clear plastic tamper-evident clamshell.
  12. 15 oz Veggie Rice Blend – UPC 8 13055 01014 2; with the expiration dates of 01/07/21 and 01/09/21 noted on the bottom scan labels. The brand name is Lancaster Foods and the package is a stand-up steam pouch with ‘grab & steam’ printed on the header.

Out of an abundance of caution, Lancaster Foods has temporarily halted production of these items as the FDA and the company investigate the source of the issue. Consumers who have purchased units noted above are urged to return them to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-410-799-0010, extension 1530. The hours are from 0800 to 1700 in the Eastern time zone on the days of Monday through Sunday. Voicemails received after hours will be returned the next day.


Company Contact Information

Consumers:
Lancaster Foods, LLC
 1-410-799-0010, extension 1530

Product Photos

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