Category Archives: FDA

USA -FDA Investigating a Multistate Outbreak of Salmonella Concord Linked to Tahini Produced by Achdut Ltd

FDA

Salmonella

 

November 27, 2018

United States Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC), and state and local partners, is investigating a multistate outbreak of Salmonella Concord illnesses linked to tahini imported from an Israeli manufacturer, Achdut Ltd., located in Ari’el, Israel.

Achdut Ltd. has voluntarily recalled all brands of tahini products manufactured from April 7, 2018 to May 21, 2018 with expiration dates of April 7, 2020 to May 21, 2020.

Recommendations

The FDA is advising consumers not to eat recalled Achva, Achdut, Soom, S&F, Pepperwood, and Baron’s brand tahini with expiration dates ranging from April 7, 2020 to May 21, 2020. The product lot codes range from 18-097 to 18-141. Consumers should discard the product or return the product to the store for a refund.

Some brands of tahini manufactured by Achdut Ltd. may lack specific dates or may have labels that are written in Hebrew. Consumers who have purchased a tahini product and are uncertain of where the product was manufactured or cannot identify the brand by lot codes or expiration dates should use caution and discard the product or return the food to the store for a refund. More product information and pictures of the recalled product labels can be found in the firm’s recall announcement.

Retailers and restaurants should not use any of the recalled tahini manufactured by Achdut Ltd. at their establishments. Retailers and restaurants should throw the product out.

Firms that may have used the recalled tahini (either repacked or used as an ingredient in a food without a kill step) should consider recalling their products. Recalls should be reported to your local FDA office. A list of recall coordinators can be found here.

Consumers who have symptoms of salmonellosis should contact their health care provider to report their symptoms and receive care.

Background

CDC identified five ill people in the U.S. infected with Salmonella Concord that had the same genetic fingerprint as the Salmonella Concord found in tahini sampled at the point of import into the United States. Of the five U.S. cases interviewed, all five reported consuming hummus made with tahini; three people reported eating tahini or hummus made with tahini in a restaurant in the U.S., while the other two people reported consuming tahini or hummus made with tahini during international travel.

A sample of imported tahini collected by FDA at the point of import tested positive for Salmonella Concord. The tahini was Baron’s brand manufactured by Achdut Ltd. This manufacturer was placed on an FDA Import Alert, detaining additional product from the firm at the U.S. border until evidence is presented demonstrating that Salmonella is not present in the product. Whole genome sequencing analysis has indicated the positive sample of imported Baron’s brand tahini is highly related to clinical isolates from ill people in the U.S.

News – McCain company officials ignored signs of Salmonella, Listeria contamination.

Food Safety News 

For more than 2 1/2 years, management at the Colton, California facility of McCain Foods USA ignored positive test results for Listeria monocytogenes and Salmonella, apparently  choosing to ship the potentially contaminated vegetable and fruit products without conducting confirmation tests.

This pattern of behavior was discovered during an internal audit at the manufacturing location, according to information in the FDA’s Weekly Enforcement Report released yesterday.

“During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted,” according to the FDA report.

USA – FDA Investigated Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

FDA

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated a multi-state outbreak of Salmonella Enteritidis illnesses linked to shell eggs.

Update – October 25, 2018

As of October 25, 2018, there are 44 illnesses associated with shell eggs from Gravel Ridge Farms, in Cullman Alabama. The CDC has announced that this outbreak appears to be over.

Recommendations

The FDA advises consumers not to eat recalled shell eggs produced by Gravel Ridge Farms. Consumers who have purchased these products should discard the eggs or return them to the store for a refund. For a complete list of stores, visit the recall notice.

Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling raw eggs and raw egg-containing foods. Dishes containing eggs should be cooked to 160° F. For recipes that call for eggs that are raw or undercooked when the dish is use either eggs that have been treated to destroy Salmonella, by pasteurization or another approved method, or pasteurized egg products.

USA – Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk – Salmonella

FDA Salmonella

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural In Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

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 severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Affected product was distributed through retail sale, direct delivery, and mail order in New York, New Jersey, Vermont, Massachusetts, Washington DC, and Virginia.

USA – Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

FDA

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

RISK STATEMENT-Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals.

Eight and Company LLC, d/b/a Sprayology has not to date received any reports of adverse events related to this recall.

The products are for assorted symptom relief can be identified by the main label on the bottle and by the expiration date printed on the backside of the label. Each product recalled is an individual 1.38 oz. oral spray in white bottle manufactured at the King Bio, Inc. facility in Asheville, NC. Product was distributed nationwide via wholesale, retail and online sales.

USA – Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

FDA

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with  lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals and animals. To date, Silver Star Brands, Inc. has not received any reports of adverse events related to this recall.

These products can be identified by the main label on the bottle and the lot number that is printed on the label. Each product recalled is an individual 2 oz. oral spray in amber bottle (see table below), manufactured at the King Bio, Inc. facility in Asheville, NC.  Product was distributed nationwide via wholesale, retail and online sales.  Native Remedies®, PetAlive® and Healthful Naturals™ package images for products affected are attached (below).

HUMAN PRODUCTS
PRODUCT INDICATION NDC UPC LOT EXPIRATION DATE
Native Remedies VertiFree oral spray Temporary relief for dizziness and nausea 68703-253-02 818837012260 K061417B 6/20
Native Remedies VaricoGo oral spray Relieves discomfort associated with varicose veins 68703-105- 59 818837010419 K111717A 11/20
Native Remedies HypoSlim oral spray Assists with healthy weight management and metabolism 68703-275- 02 818837013724 K051818A 05/21
Native Remedies EyeClear Pro oral spray Relieves symptoms of mineral buildup and eye irritation 68703-151- 59 818837011652 K022317A, K022317B 02/20
Healthful Naturals DizziFree oral spray Temporarily relieves dizziness and nausea 68703-204- 02 840853166535 K022616D N/A
Healthful Naturals Leg Cramp Support Temporary relief from cramps and spasms while resting 68703-206- 02 840853166559 K022216C N/A
PET PRODUCTS
PRODUCT INDICATION NDC UPC LOT EXPIRATION DATE
PetAlive Plump-Up Pet oral spray Improves appetite in underweight dogs and cats 68703-290- 02 818837013908 K011617E 01/20
PetAlive Allergy Itch Ease oral spray Relieves skin itch 68703-135- 59 818837011102 K111617B 11/20

Silver Star Brands, Inc. is notifying its distributors and customers by letter and is arranging for return and replacement (or refund) of the recalled products.

Consumers/distributors/retailers that have this product which is being recalled should discontinue use/distribution and contact Silver Star Brands, Inc.
at Nativeremedies@silverstarbrands.com to make arrangements to return the product. These
products were distributed nationwide to retailers (doctor offices, pharmacies, health food stores) and consumers (direct sales and website).

Consumers with questions regarding this recall can contact Silver Star Brands, Inc. at 1-888- 736-6389 Monday – Friday 8:00 am – 5:00 pm CST or email Nativeremedies@silverstarbrands.com. Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to using this product.

USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora

FDA 220px-Cyclospora_cayetanensis_stained

The safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

As part of these efforts, we conduct surveys that involve collecting a robust sample of certain food commodities available in the U.S. marketplace to monitor for the presence of foodborne pathogens. Over time, the FDA has increased its surveillance sampling efforts. We’ve also advanced new technology for pursuing these efforts and expanded the list of foodborne pathogens that the FDA monitors. Owing to these efforts, including a new FDA laboratory testing method, we’ve recently been able to add screening for Cyclospora – a parasite that causes intestinal infection after people ingest something, such as fresh or uncooked produce, or water that was contaminated with human waste – to the list of foodborne pathogens that we can routinely test for in appropriate commodities.

The availability of new testing methods for Cyclospora played an important role in helping the FDA identify a number of positive samples this summer. We detected Cyclospora in domestically grown cilantro that was tested as part of an ongoing sampling assignment of herbs. This cilantro sample has not been linked to any illnesses, but it was the first time we identified Cyclospora in any domestically grown produce item.  Our domestic oversight efforts will evolve to confront this new risk.

This year has been notable for the number of cyclosporiasis cases reported by state and local health departments. Our partners at the Centers for Disease Control and Prevention (CDC) today announced that 2,173 cases of domestically acquired cyclosporiasis have been recorded this spring and summer as of Sept. 12. Although this case count represents a significant increase from our previous experience with this parasite over the last several years, some of this increase is likely the result of improved public health monitoring for human illness, including better diagnostic tests.

Many of this year’s illnesses with Cyclospora are linked to two very large produce-associated outbreaks that we announced over the last several months. One of these outbreaks occurred in the spring. It resulted in 250 illnesses in four states and was linked to Del Monte vegetable trays containing broccoli, cauliflower, and carrots that were sold mostly in convenience stores in the Upper Midwest. Our traceback efforts to determine the source of the contamination indicate that the ingredients could have come from either domestic or imported sources. While our findings were not conclusive regarding the source, we were able to work with Del Monte to voluntarily recall the vegetable trays to limit the extent of illness and on Sept. 6, the FDA and CDC declared this outbreak over.

The second outbreak occurred this summer when 511 Cyclospora illnesses were reported by 16 states. Most of these illnesses occurred in the Midwest. This outbreak was linked to McDonald’s salads sold in 14 states in the Midwest that contained a romaine lettuce and carrot mix supplied by Fresh Express. The FDA worked with McDonald’s to quickly remove implicated salad from the stores. Testing conducted by the FDA identified the parasite in an unopened package of the bagged salad mix, supporting epidemiologic evidence that the salad mix is the source of the outbreak. Fresh Express took the additional precautionary step of recalling lots of romaine lettuce outside the positive lot contained in the salad mix. On Sept. 12, the FDA and CDC announced that this outbreak had ended.

Our experts worked with both McDonald’s and Fresh Express to trace the bagged salad mix ingredients back to where they were grown. We found that the products came from primarily domestic growers. During our investigation, two samples of domestically grown romaine lettuce were also found to be positive for Cyclospora even though they were not sourced from locations associated with the lettuce that was linked to this outbreak. None of the romaine lettuce associated with these positive test results for Cyclospora went into the marketplace and all of the produce suspected of being contaminated was destroyed, preventing additional Cyclospora illnesses from occurring. However, these findings are important as they represent the second time that Cyclospora has been identified in produce grown in the U.S.

Although these two outbreaks are large, together they account for less than half of all domestically acquired Cyclospora cases reported to CDC in 2018.  As noted by CDC, smaller clusters of illness have also been identified and investigations to date have found them to be epidemiologically linked to consumption of basil and cilantro in Mexican-style restaurants. These clusters are similar to clusters of Cyclospora seen in previous years that were traced to imported herbs although our investigation into the source of the current illnesses is ongoing. That said, our market survey of fresh herbs did identify Cyclospora earlier this summer in cilantro offered for import from two producers in Mexico. In response to that finding, the FDA refused entry for these shipments and took action to prevent contaminated cilantro from those firms from entering the U.S. market.

The discovery of Cyclospora in both domestic and imported produce raise both old and new concerns. They underscore the importance of the FDA’s surveillance activities to better define risks, like investigating why different product types like vegetable trays are being linked to Cyclospora outbreaks, and how widespread Cyclospora may be in the U.S. They also stress the need to broaden the tools, like import alerts, that we have up to this point used to prevent Cyclospora illnesses in the U.S. to also include actions that are more appropriate for addressing domestic contamination events.

The findings also highlight the significance of continuing to implement the provisions of the Produce Safety Rule at home and abroad. We must continue to put in place science-based measures to prevent microbial contamination from occurring, and work with our state and foreign partners to implement the Produce Safety Rule. We’ve been working closely with the National Association of State Departments of Agriculture and our state partners to, among other things, train federal and state regulators who will conduct inspections slated to begin next spring, develop inventories of farms that are covered by the rule, put in place the Produce Safety Network to support the states and their farming communities regionally, conduct On Farm Readiness Reviews to help farmers assess their preparedness to implement the Produce Safety Rule, and continue training opportunities for the farming community. All of these efforts are part of our commitment to working every day to assure the American public of the safety of the foods you and your family purchase and consume.

The U.S. has one of the safest food supplies in the world. But we also recognize that there is more that we can do when we have new findings like we’ve seen with Cyclospora. New risks will continue to emerge. Our system needs to be rigorous, nimble, and proactive in order to confront new challenges.

I want to reinforce to consumers that it’s our goal to figure out how these outbreaks happened. We take this obligation very seriously. That’s, in part, why we are intervening early. And it’s why we’ll be communicating regularly with the public to provide information and updates on all of the outbreaks we work on.

I remain committed to strengthening our work on outbreak investigations — and to applying the FDA’s food safety expertise to protect American families and keep them safe both now and in the future. We’ll provide more updates as our investigations continue, especially when we have actionable information for consumers.

The FDA encourages consumers with questions about food safety to Submit An Inquirydisclaimer icon to the agency, or to visit www.fda.gov/fcic for additional information.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.