Category Archives: FDA

USA – CORE Response Teams – Update

FDA

000

USA – Outbreak Investigation of Listeria monocytogenes – Hispanic-style Fresh and Soft Cheeses (February 2021)

FDA

The FDA, along with CDC and state and local partners, are investigating a multistate outbreak of Listeria monocytogenes infections linked to queso fresco cheeses made by El Abuelito Cheese, Inc.

As part of this outbreak investigation, the Connecticut Department of Public Health collected product samples of El Abuelito-brand Hispanic-style fresh and soft cheeses from a store where a sick person bought cheeses. Sample analysis showed the presence of Listeria monocytogenes in samples of El Abuelito Queso Fresco sold in 10 oz packages, marked as Lot A027 with an expiration date of 02/26/2021. On 2/19/2021, Whole Genome Sequencing (WGS) analysis conducted by the Connecticut State Laboratory determined that the Listeria monocytogenes found in the samples is a match to the outbreak strain.

On 2/19/2021, El Abuelito Cheese, Inc. of Paterson, NJ recalled all Queso Fresco products with “sell by” dates through 03/28/21. Products include El Abuelito, Rio Grande, and Rio Lindo brand queso frescos, distributed to CT, MD, NC, NJ, NY, PA, and VA. A full list of recalled products is included below. At this time, El Abuelito Cheese, Inc. has ceased production and distribution of all products.

Recommendation

Consumers, restaurants, and retailers should not eat, sell, or serve any recalled queso fresco cheeses.

FDA recommends that anyone who purchased or received recalled products use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination. Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces.


Product Images

Sample Product Label from the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses (February 2021) - Rio Grande

 

Sample Product Label from the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses (February 2021) - Rio Grande

 

Sample Product Label from the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses (February 2021) - Rio Lindo

 

Sample Product Label from the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses (February 2021) - El Abuelito

 

Sample Product Label from the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses (February 2021) - Chirilagua, Yorito

 

Recall Information

On 2/19/2021, El Abuelito Cheese of Paterson, NJ recalled all Queso Fresco products within expiration. Products include:

Brand

Product Name

Size

Container Type

UPC Code

El Abuelito Cheese

Queso Fresco Regular

12 oz.

Plastic Container

673130100003

El Abuelito Cheese

Queso Fresco Promoción

10 oz.

Plastic Container

673130100078

El Abuelito Cheese

Queso Fresco de Hoja

12 oz.

Plastic Container

673130100065

El Abuelito Cheese

Queso Fresco

5 Lb.

Vaccuum Packed

673130100058

El Abuelito Cheese

Queso Fresco Guatemala

12 oz.

Plastic Container

673130100027

Rio Grande Food Products, Inc.

Chirilagua Queso de Hacienda

12 oz.

Plastic Container

738529005571

Rio Grande Food Products, Inc.

Queso Fresco Campestre con Hoja

14 oz.

Plastic Container

812324031161

Rio Grande Food Products, Inc.

Queso Fresco Campestre Artesanal

14 oz.

Plastic Container

738529002518

Rio Grande Food Products, Inc.

Queso Fresco con Hoja

14 oz.

Plastic Container

738529004581

Rio Grande Food Products, Inc.

Queso Fresco Yorito

12 oz.

Plastic Container

738529005564

Rio Grande Food Products, Inc.

Queso Fresco Olancho

14 oz.

Plastic Container

812324031222

Rio Grande Food Products, Inc.

Cuajada Fresca Guatemalteca

12 oz.

Plastic Container

738529001276

Rio Grande Food Products, Inc.

Cuajada Fresca Hondureña

12 oz.

Plastic Container

738529001269

Rio Grande Food Products, Inc.

Cuajada Fresca Salvadoreña

12 oz.

Plastic Container

738529001252

Rio Lindo

Queso Fresco Mexicano

12 oz.

Plastic Container

718122088587

Rio Lindo

Queso Fresco Hondureño

12 oz.

Plastic Container

718122088591

Rio Lindo

Queso Fresco Salvadoreño

12 oz.

Plastic Container

718122088607

U.S. Distribution of Recalled El Abuelito Queso Fresco

Product Distribution*: CT, MD, NC, NJ, NY, PA, VA

*States with confirmed distribution; product could have been distributed further


Case Count Map Provided by CDC

CDC Case Count Map for the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses - 2/12/2021

Case Counts

Total Illnesses: 7
Hospitalizations: 7
Deaths: 0
Last Illness Date: 1/22/2021
States with Cases: MD (4), CT (1), NY (1), and VA (1)

FDA – Aaron’s Gourmet Smoked Fish Recalls Smoked Fish Products Produced Without Licensure and Regulatory Oversight

FDA

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Fish
Food Compliance Programs
Reason for Announcement:
Lack of licensure and regulatory oversight by the state agency
Company Name:
Aaron’s Gourmet Smoked Fish
Brand Name:
Aaron’s Gourmet Smoked Fish
Product Description:
Smoked fish products

Company Announcement

Aaron’s Gourmet Smoked Fish is issuing a voluntary recall of all smoked fish products due to the lack of licensure and regulatory oversight by the state agency. The products are packaged in both glass jars and vacuum-packed plastic bags.

The products were distributed to Growers Outlet and Berry Good PDX in Portland, Oregon. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase for a full refund.

The products have been voluntarily recalled by Aaron’s Gourmet Smoked Fish. We are not aware of any reported cases of illness related to these products.

This recall is being made with the knowledge of the Oregon Department of Agriculture.

Please contact Aaron at 503-372-9849 for questions or complaints.


Company Contact Information

Consumers:
Aaron
 503-372-9849

USA – FDA – Enforcement Report – Week of February 17, 2021

FDA

Product Description:
“LAVVA Blueberry Dairy Free Pili Nut Yogurt. NO SUGAR ADDED. NET WT 5.3OZ (150g) ***KEEP REFRIGERATED***DISTRIBUTED BY EVR FOODS INC. NEW YORK, NY 10010″
Reason for Recall:
Product may contain mold.
Product Quantity:
” 806 cases (9,672 units)
Recall Number:
F-0287-2021
Code Information:
Unit UPC: 00860149001739 Case UPC: 10860149001736 Best By: 2/21/21
Classification:
Class II

Product Description:
Butternut Veggie Spirals Tray, Keep Refrigerated, NET WT 9.5oz (269g)
Reason for Recall:
Butternut Squash products potentially contaminated with Listeria monocytogenes.
Product Quantity:
3,570 cases
Recall Number:
F-0281-2021
Code Information:
Run No./Use by Date: 1222496F/ 1/13/2021, 1222747F/ 1/14/2021, 1222831F/ 1/15/2021, 1222851F/ 1/16/2021, 1222959F/ 1/17/2021, 1223108F/ 1/18/2021, 1223145F/ 1/19/2021, and 1223223F/ 1/20/2021.

Product Description:
Butternut Cubed Butternut Tray, Keep Refrigerated, NET WT 13oz (368g)
Reason for Recall:
Butternut Squash products potentially contaminated with Listeria monocytogenes.
Product Quantity:
7,111 cases
Recall Number:
F-0282-2021
Code Information:
Run No./Use by Date: 1222496F/ 1/13/2021, 1222747F/ 1/14/2021, 1222831F/ 1/15/2021, 1222851F/ 1/16/2021, 1222959F/ 1/17/2021, 1223108F/ 1/18/2021, 1223145F/ 1/19/2021, and 1223223F/ 1/20/2021.
Classification:
Class II

Product Description:
Butternut Squash Tray, Keep Refrigerated, NET WT 12oz (341g)
Reason for Recall:
Butternut Squash products potentially contaminated with Listeria monocytogenes.
Product Quantity:
359 cases
Recall Number:
F-0283-2021
Code Information:
Run No./Use by Date: 1222496F/ 1/15/2021, 1222747F/ 1/16/2021, 1222959F/ 1/19/2021, and 1223223F/ 1/22/2021.
Classification:
Class II

Product Description:
Reese Bearnaise Sauce packaged in glass jars 7.5 oz UPC: 7067060109
Reason for Recall:
Reports of compromised vacuum seal and product expansion which may lead to growth of microorganisms
Product Quantity:
653 cases (12 packages per case)
Recall Number:
F-0277-2021
Code Information:
Best by 11/13/2022
Classification:
Class II

Product Description:
Reese Hollandaise Sauce packaged in glass jars 7.5 oz UPC: 7067060108
Reason for Recall:
Reports of compromised vacuum seal and product expansion which may lead to growth of microorganisms
Product Quantity:
1600 cases (12 packages per case)
Recall Number:
F-0278-2021
Code Information:
Best by 11/16/2022
Classification:
Class II

Product Description:
Butternut Squash Bag, 5 lbs
Reason for Recall:
Butternut Squash products potentially contaminated with Listeria monocytogenes.
Product Quantity:
155 cases
Recall Number:
F-0285-2021
Code Information:
Run No./Use by Date: 1222496F/ 1/13/2021, 1222831F/ 1/15/2021, 1223108F/ 1/18/2021, and 1223198F/1/20/2021.
Classification:
Class II

USA – CORE Investigation Table – Updates

FDA

FDA

12/23/2020

11

Salmonella Potsdam

Not Yet Identified

1/13/2021

10

Salmonella Miami

Not Yet Identified

2/17/2021

14

E. coli O157:H7

Not Yet Identified

2/17/2021

15

Listeria monocytogenes

Hispanic-style fresh and soft cheese

 

USA – Outbreak Investigation of Listeria monocytogenes – Hispanic-style Fresh and Soft Cheeses (February 2021)

FDA

The FDA, along with CDC and state and local partners, are investigating a multistate outbreak of Listeria monocytogenes infections potentially linked to Hispanic-style fresh and soft cheeses.

FDA has initiated an investigation and is collecting information to try to determine the source of the outbreak. Although the investigation is ongoing, CDC’s analysis of epidemiologic information indicates that Hispanic-style fresh and soft cheeses are the leading hypotheses for the cause of the illnesses. No specific type or brand of cheese has been confirmed as the source of illness. CDC reported that seven people infected with the outbreak strain of Listeria monocytogenes have been reported in Connecticut, Maryland, New York, and Virginia. Six of the seven ill people are Hispanic. Of the four people interviewed, three reported eating at least one type of Hispanic-style fresh and soft cheeses, and each of the three reported eating queso fresco.

As part of this outbreak investigation, the Connecticut Department of Public Health collected product samples of El Abuelito-brand Hispanic-style fresh and soft cheeses from a store where a sick person bought cheeses. Sample analysis showed the presence of Listeria monocytogenes in samples of El Abuelito Queso Fresco sold in 10 oz packages, marked as Lot A027 with an expiration date of 02/26/2021. Samples are currently undergoing Whole Genome Sequencing (WGS) analysis to determine if the Listeria monocytogenes found in these samples is a match to the outbreak strain. At this time, there is not enough evidence to determine if this outbreak is linked to El Abuelito Queso Fresco.

FDA and state partners are working with the firm to recall the affected lot and to determine if additional products should be recalled. Additional information will be provided as it becomes available.

Recommendations

Consumers, restaurants, and retailers should not eat, sell, or serve El Abuelito Queso Fresco cheese until more information is known.

If you are at higher risk for severe Listeria illness (if you are pregnant, aged 65 or older, or have a weakened immune system due to certain medical conditions or treatments) do not eat any Hispanic-style fresh and soft cheeses, including El Abuelito brand queso fresco cheese, until we identify which cheeses are making people sick in this outbreak.

Call your healthcare provider right away if you have these symptoms after eating Hispanic-style fresh and soft cheeses:

  •  Pregnant people typically experience only fever, fatigue, and muscle aches. However, Listeria infection during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
  •  People who are not pregnant may experience headache, stiff neck, confusion, loss of balance, and convulsions, in addition to fever and muscle aches.

Generally, make sure the Hispanic-style fresh and soft cheeses (like queso fresco) you eat have labels that state, “Made with pasteurized milk.”

Be aware that Hispanic-style fresh and soft cheeses made from pasteurized milk have caused Listeria outbreaks. Although pasteurization of milk kills Listeria, products made from pasteurized milk can still become contaminated if they are produced in facilities with unsanitary conditions.

Restaurants and retailers that serve or sell Hispanic-style fresh and soft cheeses should follow FDA’s safe handling and cleaning advice.


Case Count Map Provided by CDC

CDC Case Count Map for the Outbreak Investigation of Listeria monocytogenes in Hispanic-style Fresh and Soft Cheeses - 2/12/2021

Case Counts

Total Illnesses: 7
Hospitalizations: 7
Deaths: 0
Last Illness Date: 1/22/2021
States with Cases: MD (4), CT (1), NY (1), and VA (1)

USA -CORE Table Updates

FDA

The following is a list of outbreak investigations being managed by FDA’s CORE Response Teams. These two investigations are still active.

2/23/202011Salmonella PotsdamNot Yet Identified7ActiveEnded
See Advice
 
1/13/202110Salmonella MiamiNot Yet Identified61ActiveOngoing
See Advice
   

USA – Shenandoah Growers, Inc Issues a Limited, Voluntary Recall of Specific Imported Organic Basil Because of Potential Health Risk – Cyclosporiasis

FDA

Company Announcement

Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 3240 units of branded fresh cut, packaged organic basil clamshells packed at its Indianapolis, Indiana location due to a possible health risk from Cyclospora.

Cyclosporiasis is an intestinal infection caused by the Cyclospora parasite. A person may become infected after ingesting contaminated food or water. Common symptoms include severe abdominal pain, watery diarrhea, nausea and vomiting, body aches and fatigue. The infection is treated with antibiotics and most people respond quickly to treatment.

Only the following specific lot codes are affected:

PV40515 1034     PV40515 3034     PV40515 4034     PV40515 3035

The affected product has a country of origin of Colombia and was harvested entirely from Puerto Vallarta Herbs SAS (Farm) and imported by Vallarta Organics LLC dba Organic Destiny (Importer).

Affected lot codes shipped:

Lot Code: Pack Date: Brand: Size: Location UPC:
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 0.75 oz Indianapolis Fruit 7-68573-00101-4
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 2.0 oz Indianapolis Fruit 7-68573-02143-2
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 4.0 oz Indianapolis Fruit 7-68573-00141-0
PV40515 3034 2/3/2021 That’s Tasty (Pasta Blend) 0.5 oz Vine Line Produce 7-68573-52008-9
PV40515 3034 2/3/2021 That’s Tasty 0.5 oz Vine Line Produce 7-68573-50502-4
PV40515 3034 2/3/2021 Shenandoah Growers by That’s Tasty 4 oz Vine Line Produce Bulk N/A
PV40515 3034 2/3/2021 Shenandoah Growers by That’s Tasty 1 lb. Vine Line Produce Bulk N/A
PV40515 4034 2/3/2021 Simple Truth 3.0 oz Kroger 0-11110-00876-3
PV40515 1034 2/3/2021 That’s Tasty 0.25 oz J&J Distributing 7-68573-02515-7
PV40515 1034 2/3/2021 Shenandoah Growers by That’s Tasty 0.75 oz J&J Distributing 7-68573-00101-4
PV40515 3035 2/4/2021 That’s Tasty 3.0 oz Schnucks 7-68573-53001-9

Recalled products were distributed to select retail stores between 2/3/2021 to 2/4/2021 in the following states: Illinois, Indiana, Iowa, Michigan, Minnesota, Mississippi, Missouri, Ohio, Tennessee, and Wisconsin.

This recall notification is being issued due to a single instance in which a sample of bulk product was pulled at the port of entry in Miami and tested by the FDA as part of routine surveillance and indicated the potential presence of Cyclospora.

Affected Shenandoah Growers customers have been notified of the recall and instructed to immediately remove and discard recalled products from all store shelves, distribution and other inventories to ensure they are no longer available for sale or consumption.

The Shenandoah Growers recall includes only those clamshells of certified organic basil clearly marked with the affected lot codes listed above. The lot code can be found printed on each clamshell.

No other Shenandoah Growers products are subject to recall, and the company has no knowledge of any illness reported or related to this product to date.

Consumers who may have a recalled basil product should discard it immediately and not eat it. Consumers with questions, or to obtain refunds, may contact the Shenandoah Growers Consumer Response Center at 844-896-6939 Monday through Friday, 8 am to 5 pm EST.

Shenandoah Growers takes food safety matters very seriously, and stringently follows all mandated regulations and implements preventive measures designed to minimize potential risks. Shenandoah Growers is working in close coordination with regulatory officials, including the FDA, on this matter.

Company Contact Information

Shenandoah Growers Consumer Response Center
844-896-6939


Company Contact Information

Consumers:
Shenandoah Growers Consumer Response Center
 844-896-6939

USA – FDA CORE Response Team Update

FDA

core

USA – Outbreak Investigation of E. coli – Leafy Greens (December 2020)

FDA

Total Illnesses: 40
Hospitalizations: 20 (4 Cases HUS)
Deaths: 0

The FDA, along with CDC and state and local partners, investigated a multistate outbreak of E. coli O157:H7 infections in the fall of 2020. The epidemiology and traceback investigation have determined that the outbreak was linked to leafy greens. The epidemiological and traceback investigations were not able to determine a specific type of leafy green linked to illnesses. On 12/22/2020, the CDC announced that this outbreak appears to be over. This outbreak, announced by FDA and CDC on October 28, 2020, was caused by a strain of E. coli that is genetically related to a strain linked to the fall 2019 romaine outbreak.

The FDA completed a traceback investigation of multiple types of leafy greens identified in patient interviews. Although no single ranch was identified as a common source of the leafy greens, FDA and state partners also conducted on-site investigations on farms of interest.

Teams were deployed to dozens of ranches in the region to conduct large scale environmental sampling. Additionally, no Shiga toxin-producing E. coli were found on leafy greens. As part of the field investigation, teams conducted environmental sampling on and around ranches of interest to identify any factors that could have led to contamination. Samples of soil, scat or animal droppings, compost, water, and other environmental sources were collected and analyzed.

Laboratory analysis of samples is now complete. The analysis has confirmed a positive match to the outbreak strain in a sample of cattle feces, which was collected during follow-up investigations on a roadside, uphill from where leafy greens or other food identified in the traceback investigation were grown. While the finding does not provide definitive information on how E. coli may have contaminated product during the growing and harvesting season, it does confirm the presence of a strain of E. coli O157:H7 that causes recurring outbreaks in a more narrowly defined growing region and a potential, continued source of contamination.

At this time, FDA’s investigational activities have concluded. The FDA continues to review the findings from this outbreak and a detailed report will be released in the near future. This report will include recommendations shaped by the investigation findings.

In the meantime, as recommended in our Leafy Greens Action Plan, the FDA continues to recommend growers assess and mitigate risk associated with adjacent and nearby land use practices, particularly as it relates to the presence of livestock, which are a persistent reservoir of E. coli O157:H7 and other STEC.

Recommendation

CDC has declared this outbreak to be over. There is no recommendation for consumers, retailers, or suppliers.