Category Archives: FDA

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.

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.