Category Archives: FDA

USA -World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads Contamination

FDA Clost

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom+CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, recalled due to Salmonella contamination, where Blissful Remedies was listed as the recalling firm instead of World Organix LLC. To date, World Organix LLC has not received reports of adverse events related to these recalls.

Immunodeficient individuals have a higher probability of developing a disseminated potentially life threatening infection when ingesting or otherwise orally exposed to solutions contaminated by microorganisms.

USA – Pet Food -G & C Raw, LLC Recalls Pat’s Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

FDA

G & C Raw, of Versailles, OH is recalling 30 1–lb containers of Pat’s Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products. Furthermore, there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Ground Lamb Dog Food, Net Wt. 2lbs

Pat's Cat Ground Turkey  Cat Food, Net Wt. 1lb

 

USA -Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

FDA 

Listeria kswfoodworld food safety food poisoning

Image CDC Enter a caption

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contaminatLipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenesis 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.

The products were produced on July 17, 2018 and distributed to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

 

Brand Product Lipari Product # Weight Sell By Date Lot # UPC
Premo Brand Turkey & Swiss Sub 915537 4/6 OZ 08/06/2018 17201807 612510001042
Fresh Grab Turkey & Swiss Sub 251694 18/6 OZ 08/06/2018 17201807 612510001042

Products were distributed under the following brand names: Premo Brand & Fresh Grab.

USA – FDA Fast Facts: FDA works with partners to investigate a Cyclospora outbreak potentially associated with McDonald’s salads

FDA Cyclospora_LifeCycle201

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, along with state and local officials, are investigating a multi-state outbreak of Cyclospora infections. Yesterday, the Illinois and Iowa Health Departments identified McDonald’s salads as being potentially linked to cases of Cyclospora in both states. McDonald’s has voluntarily stopped selling salads at affected restaurants across 14 states and the CDC reports that 61 people across seven states have gotten sick.

“We understand how important it is to quickly identify the cause of this foodborne outbreak to help reduce additional illness and we’re working closely with our colleagues at CDC and state partners to get more answers. There’s still a lot to learn about this outbreak, and we appreciate that McDonald’s has removed salads from the menu in impacted restaurants while we work to determine whether they are in fact linked to the outbreak. We will continue to share our progress toward these goals and provide updates as we learn more,” said FDA Commissioner Scott Gottlieb, M.D. “It’s early in the investigation, but we are taking steps now to help ensure consumers know about the potentially contaminated product so that they can better protect themselves or seek treatment, especially if they have signs or symptoms of a Cyclospora infection. This is especially important as Cyclospora is not commonly tested for in a health care setting, so consumers who may think they have been exposed should raise their concerns with their health care professional.”

As part of this emerging investigation, the FDA is actively working with McDonald’s to identify the common ingredients in the salads identified by those who became sick and to trace back those ingredients through the supply chain.

Cyclospora is a parasite that can cause severe intestinal illness, but can be treated. Although it’s unknown exactly how food and water become infected with Cyclospora, people should be aware that rinsing or washing food is not likely to remove it.

The following is an update on the FDA’s ongoing investigation into this outbreak.

USA – FDA Advises Consumers to Avoid Potentially Contaminated Fresh Crab Meat Imported from Venezuela due to Vibrio parahaemolyticus

FDA 

CDC Vibrio

The U.S. Food and Drug Administration is working with federal, state, and local officials regarding a Vibrio parahaemolyticus outbreak linked to fresh crab meat from Venezuela. At this time, the FDA is advising consumers to avoid eating fresh crab meat from Venezuela, as it may be contaminated with Vibrio parahaemolyticus. Consumers are advised to ask where their crab meat is from, if dining out at a restaurant or in grocery stores. This product is commonly found in plastic tubs and may be labeled as “pre-cooked.” As this is an ongoing investigation, the FDA will share additional updates as soon as information becomes available. The FDA and the states are conducting an investigation to determine the source of contaminated fresh crab meat and ensure it is removed from the food supply. Retailers should not serve or sell fresh crab meat imported from Venezuela.

As of July 12, 2018, there are 12 cases of Vibrio parahaemolyticus. The states reporting cases associated with this outbreak include  Maryland (8), Louisiana (2), Pennsylvania (1), and the District of Columbia (1). Four of these cases are confirmed matches to the outbreak strain by Pulsed Field Gel Electrophoresis (PFGE), which is a type of DNA fingerprinting. All four of these confirmed cases are in Maryland. Four people (33%) have been hospitalized. Illnesses started on dates ranging from April 1, 2018 to July 3, 2018.

Food contaminated with Vibrio parahaemolyticus may look, smell, and taste normal.

USA – Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

FDA

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

Approximately 10,000 units of Zesty Sprouting Mix were distributed online and in retail stores nationwide since December 2017.

Recalled products include:

UPC Code Description Lot Number Best By Date
733739072719 NOW Real Food® Zesty Sprouting Mix, 16 oz. 3031259 (located on back of package) 12/20
733739072719 NOW Real Food® Zesty Sprouting Mix, 16 oz. 3038165 (located on back of package) 01/21

No other products are affected or are involved in this recall. No illnesses have been reported to date.

USA – FDA Investigated Multistate Outbreak of Salmonella Braenderup Linked to Shell Eggs from Rose Acre Farms – Appears to be Over.

FDA 

Fast Facts

  • The FDA advised consumers not to eat recalled eggs produced by Rose Acre Farms’ Hyde County farm. According to Rose Acre Farms’ recall notice and the subsequent recall from Cal-Maine Foods, Inc., these eggs are sold under multiple brand names, including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, Sunshine Farms, Publix, and Sunups. Recalled eggs were also sold to restaurants.
  • CDC reported 45 cases in 10 states with 11 hospitalizations and no deaths.
  • After learning that all of the people who became ill ate eggs or egg dishes, the FDA was able to trace back the source of some of the eggs to the Rose Acre Farms’ Hyde County farm. FDA investigators then inspected the farm and collected samples for testing. FDA analysis of the samples revealed that the same strain of Salmonella Braenderup that caused the illnesses was present at the Hyde County Egg facility, tying the facility to the outbreak.
  • As a result of the findings and discussions between the FDA and the firm, Rose Acre Farms voluntarily recalled eggs from the farm in Hyde County, North Carolina. Following Rose Acre Farms’ recall, Cal-Maine Foods, Inc. voluntarily recalled eggs purchased from Rose Acre Farms and produced at the Hyde County facility.

USA – FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA

Fast Facts

  • The FDA, CDC, along with state and local officials are investigating a multi-state outbreak of Salmonella Mbandaka infections. Kellogg’s Honey Smacks sweetened puffed wheat cereal are a likely source of this outbreak.
  • The CDC reports that 73 people in 31 states have become ill. There have been 24 hospitalizations and no deaths.
  • Following discussion with FDA, CDC, and state partners, the Kellogg Company voluntarily recalled Kellogg’s Honey Smacks cereal. The recalled products were distributed across the United States including Guam and Saipan and internationally in Costa Rica, Guatemala, Mexico, the Caribbean and Tahiti. Consumers should not eat any of the recalled Honey Smacks cereal.
  • The FDA’s staff has initiated an inspection at the facility that manufactures Kellogg’s Honey Smacks and is working quickly with the company to collect additional information.
  • As this is an ongoing investigation, the FDA will update this page as more information becomes available, such as product information, epidemiological results, and recalls.
  • Consumers who have symptoms of Salmonella infection should contact their health care provider to report their symptoms and receive care. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. Most infections usually lasts 4 to 7 days and most people recover without treatment, however some people develop diarrhea so severe that they need to be hospitalized.

USA – FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA 

 

Fast Facts

  • The FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam, manufactured by Shadow Holdings dba Bocchi Laboratories at this time, as these products might be contaminated with several species within the bacteria, Burkholderia cepacia complex (Bcc).
  • Shadow Holdings dba Bocchi Laboratories has recalled certain lots of the product.
  • The FDA is investigating whether other products manufactured by Shadow Holdings dba Bocchi Laboratories may be contaminated with, Bcc, and may present a risk to consumers.
  • As of May 7, 2018, CDC reports that there are 10 confirmed cases of Bcc associated with use of Medline Remedy Essentials No-Rinse Cleansing Foam (seven in Pennsylvania, one in New Jersey and two in California). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized.
  • This cleansing foam is a product used for skin and perineal care. It is used in hospitals and home-health care settings for people who are unable to shower or bathe after surgery or due to other acute health conditions. FDA is particularly concerned about contamination in this product, since product instructions do not include rinsing the product from patient skin. This poses a risk to persons who might be immunocompromised or have other underlying medical conditions.
  • State and federal health officials have collected samples of the product from multiple locations, including affected hospitals. As of May 7, 2018, there have been multiple product samples that tested positive for Bcc. Isolates from these product samples match clinical strains isolated from case patients by Pulsed Field Gel Electrophoresis (PFGE). Additionally, an environmental swab collected at Shadow Holdings, dba Bocchi Laboratories during FDA’s investigation has tested positive for a strain of Bcc. Given these positive samples, the FDA is advising the public to not use any Medline Remedy Essentials No-Rinse Cleansing Foam products at this time.
  • The FDA will update the public with more information as it becomes available.

USA – Seabear Company Issues a Voluntary Recall of Cold Smoked Wild Coho Salmon Lox Because of Possible Health Risk – Clostridium botulinum

FDA 

 

Seabear Company of Anacortes, Washington is voluntarily recalling 1,225/ 3 oz. units of Cold Smoked Wild Coho Salmon Lox, Gerard & Dominique Seafoods brand, affected lot # CSCO-17339, Pack Date 17-340, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

No illnesses have been reported to date.