Category Archives: FDA

USA -Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella

FDA

Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

Risk Statement: The product potentially could result in contracting salmonella. Symptoms of salmonella can include illness, vomiting, and some cases even death. This risk is higher for users a compromised or weak immune system, including elderly and young children. Sunstone Organics has not received any reports of adverse events to date related to this recall.

The product is used as a tea or supplement and is packaged in kraft stand-up pouches in both capsule form and powder form, in 3 different size bags, for a total of 12 products. The affected Sunstone Organics Kratom lots include the following lot numbers: Sunstone Organics White Vein Lot 119 and Sunstone Organics Maeng Da Lot 124A in Powder form and package sizes 25 grams, 50 grams, and 100 grams, and in capsule form in sizes 20 count, 60 count, and 150 count.

USA – Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk

FDA Front Label - WILD ALASKA, SMOKED SILVER SALMON

Smoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

The Smoked Silver Salmon was sold to distributors throughout the state of Alaska primarily in gift stores in the Anchorage and Fairbanks area.

Smoked Alaska Seafoods, Inc. produces several species of smoked salmon in flexible retortable pouches, glass jars and black two-piece metal cans.  The flexible retortable pouches are not affected by this recall.

No illnesses have been reported to date. The recall was initiated as a result of an independent audit paid for by Smoked Alaska Seafoods, Inc.  A review of the thermal processing records determined the recalled lot did not receive the prescribed thermal process and was therefore underprocessed.  Consumers should destroy the product, return it to the place where purchased for a refund or contact Smoked Alaska Seafoods, Inc. for a refund or replacement.

This recall is being made with the knowledge of US Food and Drug Administration and the Alaska Department of Environmental Conservation.

Consumers who have purchased this product and have questions or need additional information should call the company at (907) 355-5533 from 8:00 AM to 8:00PM Alaska time.

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.