The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.
"I and love and you" Expands Voluntary Recall of Beef Gullet Strips Due to Possible Health Risk
NatPets LLC, d/b/a “I and love and you,” of Boulder, CO (the “Company”), is expanding its voluntary recall of cow-boom! strips – beef gullet because the product has the potential to be contaminated with Salmonella.
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Picnic Gourmet Spreads Issues Recall for Potential Health Risks
Out of an abundance of caution, Picnic Gourmet Spreads is issuing a recall on their yogurt cheese spreads. These spreads could potentially be contaminated with Listeria monocytogenes.
FDA awards 18 grants to stimulate product development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.
Butala Emporium, Inc. Recalls Eleven Ayurvedic Dietary Supplements Because of Elevated Levels of Lead and Mercury
Butala Emporium, Inc of Jackson Heights, NY, is voluntarily recalling eleven Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders if consumed.The concentration of lead exceeds the recommended daily lead exposure for children less than 6 years of age and women of childbearing age and would likely be injurious to health.
FDA approves new drug to treat schizophrenia and bipolar disorder
The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
Karoun Dairies, Inc. Issues Nationwide Voluntary Recall of Various Cheeses Because of Possible Health Risk
Today Karoun Dairies, Inc. announced that it is voluntarily recalling a variety of cheeses it distributes due to possible contamination with Listeria monocytogenes. To date, no product has tested positive for Listeria but in view of the association with listeriosis cases Karoun Dairies Inc. is initiating a voluntary recall in the interest of protecting public health.
Thoratec Issues Voluntary Device Correction
Thoratec Corporation (NASDAQ: THOR) today issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use. This backup battery has a 36 month expiration date.
Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Federal Court for the Northern District of Iowa
Iowa Select Herbs, LLC (the “Company”) is conducting a consumer recall for inventory sold between January 1, 2015 and August 17, 2015 pursuant to a Consent Decree issued by the federal court for the Northern District of Iowa. The Consent Decree was issued because the Company manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated.
Potential Health Hazard: Recalled Snack Fresh Brand Red Apple Slices May Have Been Distributed To Florida’s Palm Beach County School District
Appeeling Fruit Inc. in Dauberville, Penn. has been informed by one of its customers that some of the Snack Fresh brand, 2 oz. bagged red apple slices with Best-if-Used-by date 09/21/15 and production date 310815 that was voluntarily recalled on Wednesday, September 9 due to the potential of being contaminated with listeria monocytogenes may have been distributed to schools in Florida’s Palm Beach County School District (product photo is available at www.appeelingfruit.com). Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.