Category Archives: FDA

USA – FDA – Core Outbreak Table – Update

FDA

What’s New

  • On 4/11/2023, an updated outbreak advisory was issued for the outbreak of hepatitis A virus linked to frozen organic strawberries (reference #1143).
  • The outbreak of Listeria monocytogenes (ref #1127) linked to enoki mushrooms has ended and the FDA investigation is closed.
Date
Posted
Ref Pathogen
or
Cause of
Illness
Product(s)
Linked to
Illnesses

(if any)
Total
Case
Count

Status
3/29/2023 1141 Salmonella Infantis Raw Flour See
CDC
Investigation
Notice
Active
3/8/2023 1144 Salmonella Hartford Not Yet
Identified
53 Active
3/1/2023 1143 Hepatitis A Virus Frozen Organic
Strawberries
See
Outbreak
Advisory
Active
2/15/2023 1123 Listeria
monocytogenes
Not Yet
Identified
See
CDC
Investigation
Notice
Active

USA – Update – Outbreak Investigation of Hepatitis A Virus Infections: Frozen Strawberries (February 2023)

FDA

Product

California Splendor Recall: Kirkland Signature 4-lb. bag Frozen Organic Whole Strawberries in certain states with specific lot codes.

Scenic Fruit Recall: frozen organic strawberries with the following brand names and Best By Dates distributed to specific states:

  • Simply Nature, Organic Strawberries, Best By 06/14/2024
  • Vital Choice, Organic Strawberries, BEST BY 05/20/2024
  • Kirkland Signature, Organic Strawberries, Best If Used By 10/08/2024
  • Made With, Organic Strawberries, Best Before 11/20/2024
  • PCC Community Markets, Organic Strawberries, Best By 29/10/2024
  • Trader Joe’s, Organic Tropical Fruit Blend with the following Best By dates: 04/25/24; 05/12/24; 05/23/24; 05/30/24; 06/07/24

Stores Affected

California Splendor supplied recalled product to Costco stores in Los Angeles and Hawaii, and to two San Diego business centers. Scenic Fruit supplied recalled product to Costco, Aldi, KeHE, Vital Choice Seafood, and PCC Community Markets in specific states, and to Trader Joe’s nationwide.

On March 17, 2023, the retailer, Meijer, also issued press to voluntarily recall Made-WithExternal Link Disclaimer brand frozen organic strawberries from certain market store locations.

This is not an exhaustive list of products or stores. FDA is continuing to work with the firms to identify potential additional product information.

Symptoms of Hepatitis A

Illness usually occurs within 15 to 50 days after eating or drinking contaminated food or water. Symptoms of hepatitis A virus infection include fatigue, nausea, vomiting, abdominal pain, jaundice, dark urine, and pale stool. In some instances, particularly in children under the age of six, hepatitis A infection may be asymptomatic.

Status

Ongoing

Recommendation

  • Consumers, restaurants, and retailers should not sell, serve, or eat recalled frozen strawberries. These recalled products should be returned or thrown away.
  • If consumers purchased the recalled frozen organic strawberries and ate those berries in the last two weeks, and have not been vaccinated against hepatitis A, they should immediately consult with their healthcare professional to determine whether post exposure prophylaxis (PEP) is needed. PEP is recommended for unvaccinated people who have been exposed to hepatitis A virus in the last two weeks because vaccination can prevent a hepatitis A virus infection if given within 14 days of exposure. Those with evidence of previous hepatitis A vaccination or previous hepatitis A virus infection do not require PEP.
  • Contact your healthcare provider if you think you may have symptoms of a hepatitis A virus infection after eating these frozen organic strawberries, or if you believe that you have eaten these strawberries in the last two weeks.

Current Update

April 11, 2023

The FDA and CDC, in collaboration with state and local partners, are investigating an outbreak of hepatitis A virus infections linked to frozen organic strawberries imported by a common supplier from certain farms located in Baja California, Mexico. The frozen organic strawberries were sold to a variety of retailers under multiple brand labels.

Based on epidemiological data collected by CDC, 7/7 (100%) people who provided information about what they ate before becoming ill reported eating frozen organic strawberries. FDA’s traceback investigation identified a common supplier of the frozen organic strawberries. Strawberries used by this supplier were imported from certain farms located in Baja California, Mexico, in 2022. Additionally, the strain of hepatitis A virus causing illnesses this year is genetically identical to the strain that caused the outbreak of hepatitis A virus infections in 2022, which was linked to fresh organic strawberries imported from Baja California, Mexico, and sold at various retailers.


Case Counts

Total Illnesses: 7
Hospitalizations: 2
Deaths: 0
Last Illness Onset: March 26, 2023
States with Cases: WA (5), CA (2)
Product Distribution: Nationwide

USA – Meijer Recalls Select Premade Salads Due to Potential Health Risk – Listeria monocytogenes

FDA

GRAND RAPIDS, Mich., April 7, 2023 — Meijer, in conjunction with its supplier, Revolution Farms, is announcing a voluntary recall of select Fresh From Meijer premade salads because they have the potential to be contaminated with Listeria monocytogenesListeria 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 infection can cause miscarriages and stillbirths among pregnant women.

The recall is part of a broader Revolution Farms lettuce recall and includes premade salads carried at Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin. Meijer is not aware of any illnesses from Meijer brand salad products included in this recall.

The recalled premade salads have a Fresh From Meijer sticker on a clear plastic container. The following products are part of the recall:

UPC Recalled Product Name Sell By Date(s)
7-08820-30432-1 Fresh From Meijer Cranberry Spinach Shareable Salad (12 oz.) All
7-13733-07493-3 Fresh From Meijer Salad Bowl Spinach Dijon Salad (6.15 oz.) All
7-13733-24610-1 Fresh From Meijer Tomato Caprese Salad (6 oz.) All
7-13733-24611-8 Fresh From Meijer Avocado Chicken Bacon Ranch Salad (8 oz.) All
7-13733-24613-2 Fresh From Meijer Mediterranean Salad (6.5 oz.) All
7-13733-29537-6 Fresh From Meijer Shareable Garden Salad (11.5 oz.) All
7-19283-67929-1 Fresh From Meijer Michigan Harvest Salad (6.7 oz.) All
7-19283-67930-7 Fresh From Meijer Chicken BLT Salad (8.2 oz.) All
7-19283-67932-1 Fresh From Meijer Cobb Salad (8.8 oz.) All
7-19283-67933-8 Fresh From Meijer Chicken Caesar Shareable Salad (10 oz.) All
7-60236-11745-2 Fresh From Meijer Chicken Caesar Salad (6.4 oz.) All
7-60236-48832-3 Fresh From Meijer Southwest Chicken Salad (8.8 oz.) All

Customers who have purchased any of these products should immediately throw them away. A full refund can be requested at the Customer Service desk of the nearest Meijer store. Customers with questions regarding this recall can contact Meijer at 800-543-3704 from 7:00 AM – 1:00 AM (EDT) daily. Customers with questions or concerns about their health are encouraged to contact their primary care provider.

About Meijer: Meijer is a Grand Rapids, Mich.-based retailer that operates 501 supercenters, neighborhood markets, Meijer Grocery and Express locations throughout Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin. A privately-owned and family-operated company since 1934, Meijer pioneered the “one-stop shopping” concept and has evolved through the years to include expanded fresh produce and meat departments, as well as pharmacies, comprehensive apparel departments, pet departments, garden centers, toys and electronics. For additional information on Meijer, please visit www.meijer.comExternal Link Disclaimer. Follow Meijer on Twitter at twitter.com/MeijerExternal Link Disclaimer and twitter.com/MeijerPRExternal Link Disclaimer or become a fan at www.facebook.com/meijerExternal Link Disclaimer.

– ### –


Company Contact Information

Consumers:
Meijer
 800-543-3704

USA- Fresh Express Incorporated Announces Precautionary Recall of Expired Fresh Salad Kits Due to Potential Health Risk

FDA

Company Announcement

Fresh Express Incorporated is voluntarily recalling a limited quantity of three varieties of already-expired branded and private label salad kit products produced at the company’s Morrow, Georgia facility out of an abundance of caution due to a possible health risk from Listeria monocytogenes. The recalled products are no longer available for sale and no illnesses have been reported to date.

Listeria monocytogenes 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. Consumers with these symptoms should consult their health care provider.

The recall was initiated when it was learned a random sample test of a single salad kit with a Use-By Date of March 31, 2023 collected by the Georgia Department of Agriculture yielded a positive result for the Listeria pathogen.

Recalled salad items all carry Product Code GO75 and Use-By Dates of March 31 or April 2, 2023 located on the front of the package. They were distributed through retailers in the states of Florida, Georgia, North Carolina, South Carolina and Virginia. Retailers have been instructed to ensure the recalled products are removed from all inventories. Consumers who might still have the recalled products in their refrigerators should discard and not consume them.

A listing of products subject to this recall are summarized at the end of this announcement.

To obtain a refund or for more information, consumers may call the Fresh Express Consumer Response Center at (800) 242-5472 between the hours of 8 a.m. to 7 p.m. Eastern Time. Refunds are also available where purchased.

Brand Product Ounce UPC Codes Product Code Use-By Date Distribution States
Fresh Express Caesar Chopped Kit 9.40 00071279309194 G075 4/2/2023 FL, GA, NC, SC
Fresh Express Chopped Kit Chipotle Cheddar 11.3 00071279306049 G075 4/2/2023 FL, GA, NC, SC, VA
Publix Makoto Honey Ginger Salad Kit 8.75 00071279309194 G075 3/31/2023 Fl, GA, NC

Company Contact Information

Consumers:
Fresh Express Consumer Response Center
 (800) 242-5472
Media:
Donna Stephens or Barbara Hines
 (210) 802-1412 or (972) 677-8127

Product Photos

USA – FDA – Core Outbreak Table – Investigations of Foodborne Illness Outbreaks

FDA

Date
Posted
Ref Pathogen
or
Cause of
Illness
Product(s)
Linked to
Illnesses

(if any)
Total
Case
Count

Status
3/29/2023 1141 Salmonella Infantis Raw Flour See
CDC
Investigation
Notice
Active
3/8/2023 1144 Salmonella Hartford Not Yet
Identified
53 Active
3/1/2023 1143 Hepatitis A Virus Frozen Organic
Strawberries
See
Outbreak
Advisory
Active
2/15/2023 1123 Listeria
monocytogenes
Not Yet
Identified
See
CDC
Investigation
Notice
Active
11/9/2022 1127 Listeria
monocytogenes
Enoki
Mushrooms
See
Outbreak
Advisory
Active

USA – Seven Seas International USA, LLC is Voluntarily Recalling Biltmore Smoked Sockeye Salmon Because of Possible Health Risk – Listeria monocytogenes

FDA

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Fish
Foodborne Illness
Reason for Announcement:
Potential Foodborne Illness/Listeria
Company Name:
Seven Seas International USA, LLC.
Brand Name:
Biltmore
Product Description:
Biltmore Smoked Wild Sockeye Salmon

Company Announcement

Date: March 14, 2023
Sold at Publix Supermarkets only

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 295 cases of Biltmore Smoked Sockeye Salmon with production lot R4058 because Listeria monocytogenes may be present in some product. The issue was discovered through routine regulatory testing conducted by the Florida Department of Agriculture and Consumer Services. Consumers who have purchased this product with this lot code are being advised not to consume it and return it to the store where it was originally purchased for a full refund. Listeria monocytogenes can cause serious and sometimes fatal infections, especially in preschool age children, older adults, or people who are immune compromised. Additionally, it can cause miscarriages and stillbirths in pregnant women. Only packages sold prior to 14th March 2023 which have a lot code R4058 printed on the clear plastic film that protects the product are affected by this recall, please check for this code, no other production codes are affected by this recall.

Customers who have additional questions or concerns may contact Seven Seas International USA, LLC at 1(888) 627-5668 or visit their website at www.7siusa.comExternal Link Disclaimer.

Information regarding Biltmore Salmon products sold at Publix affected by this recall:

Product Name: Biltmore Smoked Sockeye Salmon
GTIN #: 007-36211-88774
Lot Code/Best By Date: R4058/April 14 2023


Company Contact Information

Consumers:
Seven Seas International USA, LLC
 1(888) 627-5668
 www.7siusa.com

Product Photos

USA – FDA Core Investigation Table Update

FDA

What’s New

  • A new outbreak of Salmonella Infantis (ref #1141) linked to a not yet identified product has been added to the table. FDA has initiated traceback. This investigation is ongoing and additional information will be provided as it becomes available.
  • For the Salmonella Hartford outbreak in a not yet identified food, the case count has increased from 50 to 53 cases.
Date
Posted
Ref Pathogen
or
Cause of
Illness
Product(s)
Linked to
Illnesses

(if any)
Total
Case
Count

Status
3/29/2023 1141 Salmonella Infantis Not Yet
Identified
12 Active
3/8/2023 1144 Salmonella Hartford Not Yet
Identified
53 Active
3/1/2023 1143 Hepatitis A Virus Frozen Organic
Strawberries
See
Outbreak
Advisory
Active
2/15/2023 1123 Listeria
monocytogenes
Not Yet
Identified
See
CDC
Investigation
Notice
Active
11/9/2022 1127 Listeria
monocytogenes
Enoki
Mushrooms
See
Outbreak
Advisory
Active

USA – FDA and Stop Foodborne Illness to Co-Host Webinar on Assessing Food Safety Culture

FDA

Today, the Food and Drug Administration (FDA) announced the seventh in the ongoing series of webinars exploring food safety culture will take place on May 11, 2023, from 3:45 pm 5:00 pm ET. The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne IllnessExternal Link Disclaimer, a non-profit public health organization.

The upcoming webinar “Live from the Food Safety Summit: Measure What You Treasure”, will focus on the importance of assessing food safety culture in an organization.

Guest speakers on May 11, include:

  • Donald A. Prater, DVM, Acting Director, Office of Food Policy and Response, FDA
  • Conrad Choiniere, PhD, Director, Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, FDA
  • Lone Jespersen, Principal and Founder, Cultivate SA
  • Vanessa Coffman, Director, Alliance to Stop Foodborne Illness
  • Brian Perry, Executive Food Safety & Quality Leader, TreeHouse Foods, Inc
  • Karleigh Bacon, Director of U.S. Supply Chain Food Safety, Science & Regulatory, McDonald’s Corporation
  • Philip Bronstein, Ph.D., Assistant Administrator, Office of Field Operations, Food Safety and Inspection Service, Food Safety and Inspection Service, USDA

The webinar series engages experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production.

Food safety culture is one of the core elements in FDA’s New Era of Smarter Food Safety blueprint, which states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs, attitudes, and, most importantly, the behaviors of people and the actions of organizations.

Register for Session 7External Link Disclaimer

To learn more about this webinar series and to listen to recordings, visit Collaborating on Culture in the New Era of Smarter Food Safety.

For More Information 

USA – FDA Warning Letter – Mariscos Bahia, Inc. – Salmonella Outbreak

FDA

The United States Food and Drug Administration (FDA) and the California Department of Public Health (CDPH) inspected your seafood processing facility, Mariscos Bahia Inc, located at 8300 Rex Rd., Pico Rivera, CA 90660-3719 from October 6 to October 21, 2022. The inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Litchfield (S. Litchfield) infections linked to seafood, including fresh, raw salmon, supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), 39 people from 4 states were infected with the outbreak strain of S. Litchfield. During our inspection we collected environmental samples (swabs) from various areas in your facility, including areas that are near food during processing operations. FDA laboratory analyses found the presence of the outbreak strain of S. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in your facility. On October 20, 2022, your firm recalled various types of fresh fish processed at your facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at your facility was the likely source of this multistate S. Litchfield outbreak.

USA – FDA -Core Investigation Table

FDA

What’s New

  • For the outbreak of Salmonella Hartford (ref # 1144) in a not yet identified product, the case count has increased from 47 to 50 cases. FDA has also initiated an onsite inspection and sample collection and analysis.
Date
Posted
Ref Pathogen
or
Cause of
Illness
Product(s)
Linked to
Illnesses

(if any)
Total
Case
Count

Status
3/8/2023 1144 Salmonella Hartford Not Yet
Identified
50 Active
3/1/2023 1143 Hepatitis A Virus Frozen Organic
Strawberries
See
Outbreak
Advisory
Active
2/15/2023 1123 Listeria
monocytogenes
Not Yet
Identified
See
CDC
Investigation
Notice
Active
11/9/2022 1127 Listeria
monocytogenes
Enoki
Mushrooms
See
Outbreak
Advisory
Active