June 19, 2017
Kabir’s Bakery of Brooklyn, NY is recalling “Kabir’s Bakery Cinnamon Twist“ and “Kabir’s Bakery Cinnamon Raisin Danish” in four ounce plastic packages, all container codes, due to the presence of undeclared milk. Consumers who are allergic to milk run the risk of serious life threatening allergic reactions if they consume this product Read The Complete […]
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June 19, 2017
Rikki USA, Inc. of Redmond, WA is recalling Masa’s Gourmet Sweet and Sour Sauce, Masa’s Gourmet Curry Coconut Sauce and Masa’s Gourmet Pulled Pork BBQ Sauce because it contains undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. […]
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June 16, 2017
Willis Ocean Inc., Brooklyn, NY, is recalling its “the duck” brand “frozen steamed scomber fish”, because the product was found to be uneviscerated. The steamed scomber fish were distributed nationwide through retail stores. Read The Complete Story!
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June 16, 2017
NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is expanding the voluntary recall of Ellyndale® Nutty Infusions™ Roasted Cashew Butter – Product Code E0540, Lot# 2125155, and Ginger Wasabi Cashew Butter — Product Code E0541, Lot# 2124118, to include Roasted Almond Butter – Product Code E0545, Lot# 2124119, and Mango Chili Cashew Butter – Product […]
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June 15, 2017
While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products. Every day in the U.S., more than 2,500 youth under the age of 18 smoke their first cigarette and more than 400 […]
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June 15, 2017
Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.
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June 15, 2017
GoMacro, of Viola, Wis., is recalling a limited number of MacroBars and Thrive Bars because they have 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 […]
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June 13, 2017
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new […]
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June 8, 2017
Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency […]
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June 5, 2017
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.
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June 5, 2017
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.
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June 5, 2017
Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Western Family Onion Soup Mix, UPC 15400-03604 because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
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June 5, 2017
Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Western Family Onion Soup Mix, UPC 15400-03604 because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
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May 30, 2017
The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
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May 25, 2017
Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death after […]
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May 25, 2017
Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death after […]
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May 25, 2017
California Sun Dry Foods today issued a voluntary recall of California Sun Dry Sun-Dried Tomato Pesto because of a potentially incorrect back label on some jars. This mislabeling incident resulted in undeclared allergens (Almonds and Milk). People who have an allergy or severe sensitivity to tree nuts and milk run the risk of serious or […]
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May 25, 2017
California Sun Dry Foods today issued a voluntary recall of California Sun Dry Sun-Dried Tomato Pesto because of a potentially incorrect back label on some jars. This mislabeling incident resulted in undeclared allergens (Almonds and Milk). People who have an allergy or severe sensitivity to tree nuts and milk run the risk of serious or […]
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May 24, 2017
MusclMasster, LLC of Wheat Ridge, CO is recalling all bottles of Al-Er-G Capsules because they contain the presence of Ephedra Herb, an FDA banned ingredient. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that […]
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