Category Archives: FDA

USA – Outbreak Investigation of Listeria monocytogenes: Dole Packaged Salad (December 2021)

FDA

FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Listeria monocytogenes infections linked to Dole packaged leafy greens by epidemiologic, laboratory, and traceback data. According to the CDC, as of February 1, 2022, 17 people infected with the outbreak strain of Listeria monocytogenes have been reported from 13 states. Illnesses started on dates ranging from August 16, 2014 to December 30, 2021 (one case occurred in 2014 and the remaining cases occurred between 2018 and 2021). CDC investigated this outbreak in 2019 and 2020 but was unable to gather enough data to identify the source in the past. CDC reopened the investigation in November 2021 after reports of new illnesses.

FDA sent investigators to multiple Dole processing facilities to conduct on-site inspections while at the same time Dole initiated their own investigation. On December 22, 2021, Dole voluntarily recalled all products and brands from their Bessemer City, NC, and Yuma, AZ, facilities. On January 7, 2022, as a result of continued investigations, Dole issued a voluntary recall of additional products after Dole detected the presence of Listeria monocytogenes on equipment used in the harvesting of the raw iceberg lettuce also used in finished products processed in the Dole Springfield, OH, and Soledad, CA, facilities. These products were shipped throughout the United States and several provinces in Canada. FDA analyzed the positive sample collected by Dole from the harvesting equipment. Results from FDA’s WGS analysis showed that the strain of Listeria monocytogenes found on the harvesting equipment matches the strain causing illnesses in this outbreak.

In addition to this outbreak of listeriosis linked to packaged salads produced by Dole, FDA and CDC are currently investigating a separate Listeria outbreak linked to packaged salads produced by Fresh Express. These investigations are ongoing and additional information will be provided as it becomes available.

Recommendation

FDA recommends that anyone who 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 at refrigeration temperatures and can easily spread to other foods and surfaces.

All recalled products are now past their “Best if Used By” dates of November 30, 2021 to January 9, 2022. If consumers have expired recalled Dole salads in their homes, they should throw them away. The initial list of recalled products and the second list of recalled products are available on FDA’s website.

 


Map of U.S. Distribution of Recalled Packaged Salad

Outbreak Investigation of Listeria monocytogenes from Dole Packaged Salad - Map of U.S. Distribution of Recalled Packaged Salad (February 1, 2022)

Case Count Map Provided by CDC

Outbreak Investigation of Listeria monocytogenes from Dole Packaged Salad - CDC Case Count Map (January 31, 2022)

Case Counts

Total Illnesses: 17
Hospitalizations: 13
Deaths: 2
Last illness onset: December 30, 2021
States with Cases: IA, ID, MD, MI, MN, NC, NV, OH, OR, PA, TX, UT, WI
Product Distribution*: AL, AZ, CA, CO, CT, FL, GA, HI,  IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI

*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states

USA – FDA Enforcement Report – Bake Crafters Maple Waffle Sandwiches Recalled For Possible Listeria

FDA

Event Details

Event ID: 89363

Voluntary / Mandated: Voluntary: Firm initiated

Product Type: Food

 Distribution Pattern: Distributed to Distribution Centers in ID and PA

Recalling Firm:

Bake Crafters
10673 Lee Hwy
Mc Donald, TN 37353-4101
United States

Recall Initiation Date: 12/28/2021

Center Classification Date: 1/26/2022

Bake Crafters – Maple Waffle WG Chicken Sausage Packaged into cardboard containers 126 units per case.

F-0620-2022 – Lot Number: 21343 Product Number: 6657 Best By: 12/09/22.

Potential Listeria monocytogenes contamination

USA – FDA Warning Letter – Onofrio’s Fresh Cut, Inc. – Listeria monocytogenes

FDA

The United States Food and Drug Administration (FDA) inspected your produce processing facility located at 222 Forbes Ave., New Haven, CT 06512 from July 13, 2021 through July 29, 2021. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. FDA’s inspection resulted in an issuance of a FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found at your facility.

Based on FDA’s inspectional findings and the analytical results for the environmental samples, we have determined the RTE fresh-cut produce (e.g., onions, peppers, celery, broccoli, cantaloupe, watermelon, and kiwi) processed in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that it was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 USC 331(uu)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.External Link Disclaimer

We received your responses sent via email on August 12, 2021, and August 17, 2021, which included a summary of corrective actions you have taken or plan to take. After reviewing the inspectional findings and your responses to the observations listed in the FDA-483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

USA – Enforcement Reports – ZOCALO AJI LIMO DRIED CHILI PODS – Mould/Mold

FDA

Product Details

Product Description:

ZOCALO AJI LIMO DRIED CHILI PODS- ORGANIC, Dried Aji Peppers for consumer consumption. Product is vacuum sealed in plastic bag. Net weight per bag 1.25 oz (35 g), 6 bags per case. Product of Peru. UPC 8 32924 00879 0.The product label is read in parts: “***ZOCALO gourmet *** ORGANIC more…

Reason for Recall: Due to presence of mold on product

Product Quantity: 70 cases (6 bags per case)

Recall Number: F-0506-2022

Code Information: Product ZHR 252, Lot # 1-OALWDP-YU with best by date of March 2024.

Classification: Class II

Event Details

Event ID:  89219

Voluntary / Mandated:

Voluntary: Firm initiated

Product Type: Food

Initial Firm Notification of Consignee or Public: E-Mail

Status: Ongoing

Distribution Pattern: Distributed in CA, KY, MO,MS, MT, NM, NY, OR, TX, WA and Washington DC.

Recalling Firm:

Power Selles Imports dba Culinary Collective
12407 Mukilteo Speedway Bldg B Ste 245
Lynnwood, WA 98087-1518
United States

Recall Initiation Date: 12/13/2021

Center Classification Date: 1/14/2022

USA – Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk – Listeria monocytogenes

FDA

Steamable by Lidl, Chopped Spinach, 12 oz. bag

Company Announcement

Frozen Food Development is voluntarily recalling specific lots of Lidl branded 12-ounce packages of Frozen Chopped Spinach because the product 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.

The recalled Frozen Chopped Spinach was distributed in Lidl retail stores in GA, SC, NC, VA, MD, DE, NY, NJ, and PA.

The product comes in 12-ounce poly bags, and items included in the recall are marked with lot # R17742 or R17963 on the back of the poly bag with a best by date of 09/10/23.

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

The potential for contamination was noted after routine testing revealed the presence of Listeria monocytogenes in 12-ounce packages of Lidl Frozen Chopped Spinach.

The production of the product has been suspended while FDA and Frozen Food Development continue to investigate the source of the problem.

Consumers who have purchased 12-ounce packages of Lidl Frozen Chopped Spinach are urged to return them to the place of purchase for a full refund. Consumers with questions may contact LIDL Customer Care at 1-844-747-5435 Monday thru Saturday 8:00 AM – 8:00 PM Eastern Standard time .


Company Contact Information

Consumers:
LIDL Customer Care
 1-844-747-5435

USA – DRAFT: Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24)

FDA

Submit Comments by 

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s docket number: FDA-2021-D-0367


Docket Number:
FDA-2021-D-0367
Issued by:
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition

The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation.

The current CPG Sec. 540.525 is being revised to update FDA regulatory action guidance for sensory analysis and histamine levels in scombrotoxin-forming fish and fishery products.

The  contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this CPG, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

USA – Core Outbreak Table Update

FDA

Date
Posted
Reference
#
Pathogen
Product(s)
Linked to
Illnesses

(if any)
Investigation
Status
1/10/

2022

1050 E. coli
O121:H19
Not Yet
Identified
Active
12/29/

2021

1052 E. coli
O157:H7
Packaged Salad Active
12/20/

2021

1039 Listeria
monocytogenes
Packaged Salad Active
12/15/

2021

1048 Listeria
monocytogenes
Packaged Salad Active
9/15/

2021

1031 Salmonella
Oranienburg
Red, Yellow,
and White Onions
Active

USA – FDA Warning Letter – Greenwood Ice Cream – Listeria monocytogenes

FDA

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) ice cream manufacturing facility located at 4829 Peachtree Rd, Chamblee, GA 30341-3113, from June 22, 2021 through June 25, 2021. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.

Based on FDA’s inspectional findings and the analytical results for samples collected from your production environment, we have determined that the ice cream products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.External Link Disclaimer

We received your response to the FDA-483 on July 19, 2021, and to the environmental findings on August 20, 2021, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

USA – FDA -Enforcement Report – Roasted Russets and Asparagus – Visible Mould

FDA

Product Details

Product Description: happi foodi , Roasted Russets and Asparagus, 10 oz frozen bowl, 8 packages per case, Keep Frozen DOM- 05/20/2021

Reason for Recall: Presence of visible mold detected.

Product Quantity: 153 cases on one (1) pallet

Recall Number: F-0360-2022

Code Information: 21140_983 internal tracking Sales Order SO9425 to KeHE PMC3 1401 on retail unit

Classification: Class III

Event Details

Event ID: 

89301

Voluntary / Mandated: Voluntary: Firm initiated

Product Type: Food

Initial Firm Notification of Consignee or Public: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Status: Ongoing

Distribution Pattern: There is one Consignee : KeHE Distributors 16081 Fern Avenue, Chino, CA 91708

Recalling Firm:

Prepared Meals Co
4135 Birney Ave
Moosic, PA 18507-1301
United States

Recall Initiation Date: 12/8/2021

Center Classification Date: 1/4/2022

USA – Dole Fresh Vegetables, Inc. Announces Voluntary Recall for Certain Salads Processed at its Springfield, OH and Soledad, CA Facilities and Containing Iceberg Lettuce Due to Possible Health Risk from Listeria monocytogenes

FDA

Company Announcement

FOR IMMEDIATE RELEASE –Monterey, CA–January 7, 2022–Dole Fresh Vegetables, Inc. is voluntarily recalling from the market all Dole-branded and private label packaged salads described below processed at its Springfield, OH and Soledad, CA production facilities containing iceberg lettuce, due to a possible health risk from Listeria monocytogenes.

Listeria monocytogenes is an organism that 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.

Products subject to the voluntary recall from Springfield, OH are identified by a product lot code beginning with the letter “W” and a “Best if Used By” date between December 22, 2021 and January 9, 2022. Products subject to the voluntary recall from Soledad, CA are identified by a product lot code beginning with the letter “B” and a “Best if Used By” date between December 23, 2021 and January 8, 2022. The product lot codes are located in the upper-right-hand corner of the package (see example below). Consumers who still have any of these products in their refrigerators are urged not to consume the product and to discard it immediately. No illnesses have been reported with the products being recalled to date.

This voluntary recall notification is being issued after harvest equipment used in the harvesting of the raw iceberg lettuce material used in these finished products was tested by Dole and found to contain Listeria monocytogenes.

Listing of products subject to each of these recalls is set forth below.

Recalled salad items from the Springfield facility were distributed in the states of AL, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NY, OH, PA, SC, TN, VA and WI. Additionally, these salads were distributed in the following Canadian provinces: New Brunswick, Ontario, and Quebec. Recalled salad items from the Soledad facility were distributed in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MI, MN, MO, MS, MD, ND, NE, NV, NY, OK, OR, PA, TX, UT, VA, WA and WI. Additionally, these salads were distributed in the following Canadian provinces: Alberta, British Columbia, and Saskatchewan.

No other Dole products, including fresh fruit and field-packed fresh vegetables, are part of these voluntary recalls and are safe to consume.

Dole retailers have been advised to check store shelves and warehouse inventories to confirm that no recalled product is available for purchase by consumers.

Retailer and consumer questions about the voluntary recalls should be directed to the Dole Consumer Response Center at 800-356-3111, Monday-Friday, 8:00am to 3:00pm Pacific Time.

Dole Fresh Vegetables is coordinating closely with regulatory officials.

Product Listing on the following pages

LISTING OF PRODUCTS SUBJECT TO SOLEDAD RECALL

Product Description UPC Code
Dole 10oz Very Veggie 0-71430-01008-2
Dole 11oz Greener Selection 0-71430-00965-9
Dole 12oz American 0-71430-00933-8
Dole 12oz Garden Salad / Salade Du Jardin 0-71430-01135-5
Dole 13.25oz Country Ranch Kit 0-71430-01730-2
Dole 13oz Southwest Kit 0-71430-01701-2
Dole 16oz Value Size Shredded Lettuce 0-71430-84616-2
Dole 24oz Value Size Garden Salad 0-71430-01136-2
Dole 3lb Garden Salad 0-71430-01138-6
Dole 5.8 oz Chicken Club BLT Salad Bowl 0-71430-00123-3
Dole 6.05 oz Avocado Ranch Salad with Chicken Bowl 0-71430-00125-7
Dole 6.25 oz Backyard BBQ Salad with Chicken Bowl 0-71430-00124-0
Dole 6.25 oz Santa Fe Style Salad Bowl 0-71430-00118-9
Dole 7.25 oz Turkey & Bacon Country Cobb Salad Bowl 0-71430-00120-2
Dole 7.65oz Café Chef Salad Bowl 0-71430-00115-8
Dole 8oz Shredded Lettuce 0-71430-01065-5
Dole 9.1oz Peppercorn Ranch Chopped Kit 0-71430-00093-9
Dole 9.8oz Chopped Teriyaki Pineapple Kit 0-71430-00100-4
HEB 12oz American Salad 0-41220-35500-6
HEB 8oz Shredded Lettuce 0-41220-35521-1
HEB 9.5oz Premium Ranch Kit 0-41220791569-0
Marketside 7.45 oz Premium Avocado Ranch Bowl 6-81131-37735-5
Marketside 11.75 oz Multi-Serve Southwestern Style Salad Bowl 6-81131-42361-8
Marketside 12oz Classic Salad 6-81131-32894-4
Marketside 12oz Crisp Greens 6-81131-35503-2
Marketside 1lb Shredded Lettuce 6-81131-53209-9
Marketside 24oz Classic Salad 6-81131-32895-1
Marketside 6.35 oz Santa Fe Style Bowl 6-81131-42363-2
Marketside 6.81 oz BLT Salad Bowl 6-81131-37736-2
Marketside 7.25 oz Chef Salad Bowl 6-81131-35506-3
Marketside 7.25 oz Cobb Salad Bowl 6-81131-35507-0
Marketside 8oz Shredded Lettuce 6-81131-32896-8
Presidents Choice 12.25oz Ranch Kit / Le Choix du President Ranch Kit de Salade 0-60383-00493-4
President’s Choice 12oz Garden Salad / Le Choix du President Salade Jardiniere 0-60383-22268-0
President’s Choice 13oz Sesame Ginger Kit / Le Choix du President Sesame et Gingembre 0-60383-02320-1
President’s Choice 13oz Southwest Salad Kit / Le Choix du President Sud-Ouest 0-60383-02319-5

LISTING OF PRODUCTS SUBJECT TO SPRINGFIELD RECALL

Product Description UPC Code
Dole 10 oz Very Veggie / Ranache de Legumes 0-71430-01008-2
Dole 11 oz Greener Selection / Selection de Verdure 0-71430-00965-9
Dole 12 oz American / Melange Americain 0-71430-00933-8
Dole 12 oz Garden Salad / Salade du Jardin 0-71430-01135-5
Dole 13 oz Asian Island Crunch / Croustillante Des Iles Asiatiques 0-71430-01721-0
Dole 13 oz Southwest Salad Kit 0-71430-01701-2
Dole 13 oz Southwest Salad Kit / Salade du Sud-ouest 0-71430-01711-1
Dole 13.25 Country Ranch Kit 0-71430-01730-2
Dole 16 oz Shredded Lettuce 0-71430-84616-2
Dole 2 lb Garden Salad 0-71430-01137-9
Dole 24 oz Value Size Garden Salad 0-71430-01136-2
Dole 8 oz Shredded Lettuce 0-71430-01065-5
Dole 9.1 oz Peppercorn Ranch / Ranch et Poivre 0-71430-00098-4
Dole 9.1 oz Peppercorn Ranch Chopped Kit 0-71430-00093-9
Dole 9.8 oz Chopped Teriyaki Pineapple Kit 0-71430-00100-4
Dole 9.8 oz Chopped Teriyaki Pineapple Kit / Teriyaki A L’ananas 0-71430-00182-0
Kroger 12 oz American Blend 0-11110-91041-7
Kroger 12 oz Classic Garden 0-11110-91036-3
Kroger 12 oz Veggie Blend 0-11110-91048-6
Kroger 24 oz Classic Garden 0-11110-91037-0
Kroger 8oz. Shredded Iceberg Lettuce 0-11110-91613-6
Little Salad Bar 10 oz Caesar Salad Kit 4099100 087000
Little Salad Bar 10.65 oz. Chopped Caesar Kit 4099100263923
Little Salad Bar 12 oz Garden Salad 4099100082982
Little Salad Bar 8 oz Shredded Lettuce 4099100087963
Little Salad Bar 9 oz Italian Salad 4099100083194
Marketside 12 oz Classic Iceberg Salad 6-81131-32894-4
Marketside 12 oz Crisp Greens 6-81131-35503-2
Marketside 16 oz Shredded Lettuce 6-81131-53209-9
Marketside 24 oz Classic Iceberg Salad 6-81131-32895-1
Marketside 8 oz Shredded Lettuce 6-81131-32896-8
Presidents Choice 12 oz Garden Salad / Le Choix du President Salade Jardiniere 0-60383-22268-0
Presidents Choice 12 oz Mixed Greens / Le Choix du President Melange de Legumes- Feuilles 0-60383-00188-9
Presidents Choice 12.25 oz Ranch Kit / Le Choix du President Ranch Kit de Salade 0-60383-00493-4
Presidents Choice 13 oz. Sesame Ginger Kit / Le Choix du President Sesame et Gingembre 0-60383-02320-1
Presidents Choice 13 oz. Southwest Salad Kit / Le Choix du President Sud-Ouest 0-60383-02319-5

Company Contact Information

Consumers:
Dole Consumer Response Center
 800-356-3111
Media:
Bil Goldfield
 818-874-4647

Product Photos