The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
Category Archives: Food Safety News
FDA approves Otezla to treat psoriatic arthritis
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
FDA approves first implantable hearing device for adults with a certain kind of hearing loss
The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.
FDA approves Impavido to treat tropical disease leishmaniasis
The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Some lots of Simply Lite brand dark chocolate recalled
The U.S. Food and Drug Administration warns consumers that it has tested and found milk protein in 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A.” Milk is a major food allergen, but it is not declared as an ingredient on the label.
Infinite Herbs, LLC Voluntarily Recalls One Lot of Basil Organic Clamshells Because of Possible Health Risk
Infinite Herbs LLC of Miami, Florida is voluntarily recalling one lot of its 2.5 ounce packages of Organic Basil because of potential contamination with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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FDA allows marketing of first medical device to prevent migraine headaches
Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.
Crown Food Distributors, Inc. Issues Allergy Alert on Undeclared Sulfites and Undeclared Yellow #6 in Golden Natural Fruit Island
Crown Food Distributors, Inc. of North Bergen, NJ is recalling 25 oz. large round plastic containers of “Golden Natural Fruit Island” because they contain undeclared sulfites and undeclared FD & C yellow #6. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
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Mars Food North America Voluntarily Recalls Specific Batch and Item Number Representing Less Than 3,500 Cases
Mars Food North America is voluntarily recalling one specific production lot of UNCLE BEN’S READY RICE Original Long Grain White Rice product, representing less than 3,500 cases.
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Jinsunmi International Inc. Issues A Voluntary Recall Of Its 17.98 oz Lotte Brand Frozen Fruit Bar (watermelon flavor) Due To Undeclared Peanuts
Jinsunmi Int’l Inc. is issuing the following update regarding its previously announced voluntary recall of plastic pouch of Lotte Brand frozen fruit bar (watermelon flavor)
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