Category Archives: FDA

USA – FDA – Core Outbreak Investigation Table Update

FDA

What’s New

  • For the Listeria monocytogenes outbreak (ref# 1106) in a not yet identified product, traceback has been initiated.
  • For the Salmonella Mississippi outbreak (ref# 1097) in a not yet identified product, the case count changed from 102 to 103.
  • For the Salmonella Senftenberg outbreak (ref# 1087) in a not yet identified product, the case count changed from 27 to 30.
  • For the Salmonella Typhimurium outbreak (ref# 1095) in a not yet identified product, the case count changed from 78 to 84.
  • For the Cyclospora outbreak (ref# 1080) in a not yet identified product, the case count changed from 79 to 81

USA – Leafy Greens STEC Action Plan

FDA

Leafy greens are among the most widely consumed vegetables and an important part of an overall healthy diet. However, while millions of servings are consumed safely every day, leafy greens have been repeatedly associated with illnesses caused by Shiga toxin-producing E. coli (STEC), the most common of which is E. coli O157:H7. FDA is committed to breaking this cycle of reoccurring outbreaks.

Over the last several years the FDA and partners in the public and private sectors have worked to enhance the safety of leafy greens through the development and implementation of the Leafy Greens STEC Action Plan (LGAP). This work includes prioritized inspections, focused sampling, stakeholder engagement and collaboration, data sharing, root cause investigations, and advancements in the science of detection and prevention.

Collectively, this work has expanded our body of knowledge about how and why outbreaks linked to leafy greens have occurred, which has guided and informed the evolution of the action plan over the years. Still, we know that we cannot fix the issue of leafy green contamination on our own. Industry leadership, along with collaboration among growers, processors, retailers, state partners, and the broader agricultural community, is critical to establishing needed prevention measures and preventing foodborne illness.

The following table provides the approaches for three priority areas: Prevention, Response, and Addressing Knowledge Gaps, as well as accomplishments that have been made since the action plan launched in March 2020.

USA – FDA Core Table – Investigations of Foodborne Illness Outbreaks

FDA

What’s New

  • For the Salmonella Mississippi outbreak (ref# 1097) in a not yet identified product, the case count has increased from 99 to 100 cases.
  • For the Salmonella Senftenberg outbreak (ref# 1087) in a not yet identified food, the case count has increased from 22 to 27 cases.
  • For the Salmonella Typhimurium outbreak (ref# 1095) in a not yet identified food, the case count has increased from 73 to 78 cases.
  • For the Cyclospora outbreak (ref# 1080) the case count has increased from 75 to 79 cases.
  • For the Salmonella Braenderup outbreak (ref# 1075) the FDA investigation has closed. A product linked to illnesses was not identified.
  • The investigation associated with Dry Cereal (ref # 1064) has ended and the FDA investigation has closed with no pathogen or cause of the self-reported illnesses identified, despite extensive testing for numerous potential microbial and chemical adulterants.

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

Food Poisoning News

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.

USA – St. James Smokehouse Voluntary Recalls Scotch Reserve Scottish Smoked Salmon 4oz (Lot# 123172) Because Of Possible Health Risk – Listeria monocytogenes

FDA

Label, front of package St. James Smokehouse Scotch Reserve Scottish Smoked Salmon

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Fish
Foodborne Illness
Reason for Announcement:
Listeria monocytogenes
Company Name:
St. James Smokehouse
Brand Name:
St. James Smokehouse
Product Description:
Seafood/Fish

Company Announcement

St. James Smokehouse of Miami, Florida is voluntary recalling 93 cases of St. James Smokehouse brand, Scotch Reserve Scottish Smoked Salmon, 4oz Packages (Product of Scotland) because it has 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.

The recalled product was sold and distributed by St. James via distributors between February and June 2022. The recalled product was distributed to stores located in: Alabama, Colorado, Florida, Illinois, New Jersey, New York, Massachusetts, Washington State, Virginia and Wisconsin as well as Safeway Washington State stores.

The recalled product is St. James Scotch Reserve Scottish Smoked Salmon (Product of Scotland), 4oz packages, bearing the lot# 123172 and UPC code 060022710356.The recall is specifically this lot ONLY, NO other products, brands or lots are associated with this recall.

If consumers have products matching the above description and lot# in their possession, they should dispose of it immediately or return it to the store for a full refund.

As of Friday, September 2, 2022 no illnesses have been reported.

FDA – Core Outbreak Table – Investigations of Foodborne Illness Outbreaks

FDA

What’s New

  • An outbreak of Salmonella Mississippi (ref# 1097) in a not yet identified product has been added to the table and FDA has initiated traceback.
  • For the E. coli O157:H7 outbreak (ref# 1081) in a not yet identified food, sample collection and analysis have been initiated.
  • For the Salmonella Senftenberg outbreak (ref# 1087) in a not yet identified food, the case count has increased from 22 to 25 cases.
  • For the Salmonella Typhimurium outbreak (ref# 1095) in a not yet identified food, the case count has increased from 62 to 73 cases, an on-site inspection and sample collection and analysis has been initiated.
  • For the Cyclospora outbreak (ref# 1080) the case count has increased from 70 to 75.
  • For the Cyclospora outbreak (ref# 1084), the case count has increased from 41 to 42.
  • For the Salmonella Braenderup outbreak (ref# 1075), the case count increased from 74 to 75.
  • For the outbreak of Listeria monocytogenes (ref# 1057) linked to ice cream, FDA initiated an on-site inspection.

USA – Tai Phat Wholesalers, LLC Recalls “Three Coins Dried Mushrooms” Because of Possible Health Risk – Salmonella

FDA

1) Three Coins Dried Mushrooms Slices – Item #: 01051- Nam Meo Soi -S- 2.5 oz

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Potential to be contaminated with Salmonella
Company Name:
Tai Phat Wholesalers, LLC
Brand Name:
Three Golden Coins
Product Description:
Dried whole or sliced mushrooms

Company Announcement

Tai Phat Wholesalers, LLC of Capitol Heights, MD is recalling 4 types of packages of its “Three Coins Dried Mushrooms” because they have 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.

The recalled Dried Mushrooms were distributed in specialty retail stores in the following states: Florida, Georgia, Kentucky, Maryland, Massachusetts, Minnesota, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia.

The product comes in four different types & sizes and are in a sealed clear plastic package with a label. The different types are as follows:

1)   Three Coins Dried Mushrooms Slices – Item #: 01051- Nam Meo Soi -S- 2.5 oz
2)   Three Coins Dried Mushrooms Slices – Item #: 01276- Nam Meo Soi -L- 10.5 oz
3)   Three Coins Dried Mushrooms Whole – Item #: 01052- Nam Meo Nguyen -S- 2.5 oz
4)   Three Coins Dried Mushrooms Whole – Item #: 01277- Nam Meo Nguyen -L- 10.5 oz

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

USA – Keswick Creamery at Carrock Farm, LLC Recalls Cheese Because of Possible Health Risk – Listeria monocytogenes

FDA

Keswick Creamery

Keswick Creamery of Newburg, Pa is recalling Calverley Cheese, Vulkwin’s Folly Cheese, Vermeer Cheese, Havarti Cheese, Wallaby Cheese, Cider Washed Tomme Cheese, Feta Cheese, Whole Milk Ricotta, Bovre Cheese (plain, oregano and garlic, herbes de provence, cranberry and honey) and Quark Cheese (plain, dill and onion), because it has 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.

All Cheeses were distributed at Dupont Circle Freshfarm Market in Washington, D.C.; Takoma Park Farmers Market in Takoma Park, Maryland; Smith Meadows Farm Store in Berryville, Virginia; Oylers Organic Farms and Market in Biglerville, Pennsylvania; and Talking Breads Farm Store in Mechanicsburg, Pennsylvania.

The cheeses will be labeled from Keswick Creamery, with the cheese name on the label.

  • Calverley Cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Vulkwin’s Folly Cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Havarti Cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Vermeer Cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Wallaby Cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Cider Washed Tomme Cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Feta cheese in 4 oz to 12 oz packages, price and weight labeled in red, black, or purple ink
  • Whole Milk Ricotta, 8 oz and 16 oz clear deli container, expiration dates 7/18/22, 7/25/22, 8/1/22, 8/8/22, 8/18/22
  • Bovre Cheese (plain, oregano and garlic, herbes de Provence, cranberry and honey), 8oz clear deli container, expiration dates 7/25/22, 8/1/22, 8/8/22, 8/22/22
  • Quark Cheese (plain and dill and onion), 8 oz and 16 oz clear deli container, expiration dates 7/7/22, 8/4/22, 8/25/22

No illnesses have been reported to date.

USA – Rushdi Foods Issues a Voluntary Recall on One Lot of their Mighty Sesame Organic Tahini 10.9 oz Squeeze Bottle – Salmonella

FDA

Bottle Image:  MIGHTY SESAME CO. TAHINI, CREAMY SQUEEZABLE & READY

Rushdi Food Industries, an Israeli based manufacturer, is voluntarily recalling their Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) with the specific expiration date of 3/28/23 due t0 potential Salmonella contamination. Salmonella is 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 severs illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

This recall was initiated when the company received a notification by the FDA and the West Virginia Department of Health of the potential presence of Salmonella in this specific lot. The company has received no reports of illness or injury to date.  We immediately informed all Stores who had purchased this product within this lot code about this Recall and instructed them to remove any product which might be on their shelves.  The Facility reviewed cleaning procedures, Environmental Monitoring Program Results, Process Flow and possible Root of Contamination without any positive findings.

Only packages bearing the following Lot Code/Best by date are being recalled at this time. All products other than the ones with the affected Best by Date mentioned in the table are ok to consume.

UPC Code Description Expiration Date
858313006208 Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) 3/28/23

USA – FDA Coe Investigation Table Update

FDA

What’s New

  • An outbreak of E. coli O157:H7 (ref# 1081) in an unidentified product was added to the table and FDA has initiated a traceback investigation. CDC has issued an Investigation Notice.
  • An outbreak of Salmonella Senftenberg (ref# 1087) in an unidentified product was added to the table.
  • An outbreak of Salmonella Typhimurium (ref# 1095) in an unidentified product was added to the table and traceback has been initiated.
  • For the outbreak of Salmonella Braenderup (ref# 1075) in an unidentified product, the outbreak has ended.
  • For the outbreak of Cyclospora in an unidentified product (ref# 1084), the case count has increased from 77 to 98.
  • For the outbreak of hepatitis A illnesses linked to fresh strawberries (ref# 1066), the FDA investigation has closed and the outbreak is over.
Date
Posted
Ref
Pathogen
Product(s)
Linked to
Illnesses

(if any)
Total
Case Count

Status
8/17/

2022

1081 E. coli
O157:H7
Not Yet Identified See CDC Investigation Notice Active
8/17/

2022

1087 Salmonella
Senftenberg
Not Yet Identified 19 Active
8/17/

2022

1095 Salmonella
Typhimurium
Not Yet Identified 44 Active
8/3/

2022

1080 Cyclospora Not Yet Identified 6 Active
7/27/

2022

1084 Cyclospora Not Yet Identified 98 Active
6/29/

2022

1076 Not Yet Identified Frozen Food See Outbreak
Advisory
Active
6/22/

2022

1075 Salmonella
Braenderup
Not Yet Identified 74 Active
6/22/

2022

1072 Salmonella
Paratyphi B var. L(+) tartrate+
Not Identified 14 Closed
6/15/

2022

1070 Listeria
monocytogenes
Not Identified 12 Closed
6/8/

2022

1068 E. coli
O157:H7
Not Identified 10 Closed
6/1/

2022

1066 Hepatitis A Virus Strawberries See Outbreak
Advisory
Closed
5/25/

2022

1067 Salmonella 
Senftenberg
Peanut Butter See Outbreak Advisory Closed
4/20/

2022

1064 Not Yet
Identified
Dry Cereal 558 adverse
event reports
Active
4/13/

2022

1057 Listeria
monocytogenes
Ice Cream See Outbreak Advisory Active
3/30/

2022

1060 None
Identified
Meal Replacement
Drink
6 adverse
event reports
Closed
3/16/

2022

1055 Salmonella
Saintpaul
Not Identified 60 Closed
2/17/

2022

1056 Cronobacter
sakazakii
Powdered
Infant
Formula
See
Advisory
Active (IMG)
2/9/

2022

1040 Listeria
monocytogenes
Not Identified 20 Closed
2/2/

2022

1054 Enteroinvasive
E. coli
O143:H26
Not
Identified
16 Closed
1/10/

2022

1050 E. coli
O121:H19
Romaine 4 Closed