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recalled products 214 articles

FDA, CSPC urge parents to stop using dangerous sleep positioners

Parents and caregivers of infants are being warned not to put babies in sleep positioning products because of the risk of death due to suffocation. The warnings were issued by both the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CSPC) after reviewing reports of 12 known infant deaths associated with the products. Sleep positioners are thin mats or wedges used to either elevate the baby’s head or keep the baby in a desired position while sleeping. They are often used with infants under 6 months of age. Some manufacturers claim the products help prevent Sudden Infant ... Read More

Vials of anemia drugs recalled, potential for serious injury

Certain lots of Epogen and Procrit (epoetin alfa) used to treat anemia are being recalled because the vials may contain extremely thin glass flakes, or lamellae, that are barely visible. If these flakes make their way into the bloodstream they could cause serious adverse events including embolic, thrombotic and other vascular events as well as foreign body granuloma, local injection site reactions, and increased immunogenicity. Epogen and Procrit are produced by Amgen and are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy. The glass flakes are the result of the interaction of the ... Read More

FDA cracks down on hormone-enhancing ‘dietary supplements’

The Food and Drug Administration (FDA) is cracking down on a group of products marketed as “dietary supplements” and sold over-the-counter at retail outlets and online because they contain aromatase inhibitors, a class of drugs commonly known as ADTs and used in the treatment of breast cancer and ovarian cancer in postmenopausal women. Not only do ADTs carry a host of adverse events – such as decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure and liver dysfunction – use in these “dietary supplements” means the supplements do not meet the definition ... Read More

Jury awards athlete’s family $131 million for defective seat belt, rollover

Nearly ten years after the death of 22-year-old Brian Cole, whose life was cut short when he was thrown from a 2001 Ford Explorer in an accident, a Mississippi jury has awarded the man’s family $131 million in damages. The verdict is the largest award ever against Ford Motor Co. in a lawsuit involving a Ford SUV. Cole was a former Meridian High School standout and top New York Mets baseball prospect when he was killed on March 31, 2001. According to the plaintiffs’ lawsuit, Cole was driving home to Mississippi on I-10 after spring training in Port St. Lucie, ... Read More

FDA proposes to remove low blood pressure drug from market

The Food and Drug Administration (FDA) wants to withdraw its approval of midodrine hydrochloride, a medication used to treat the low blood pressure condition orthostatic hypotension, because post-approval studies that verify the clinical benefit of the drug have not been done. This is the first time the agency has issued a withdraw proposal for a drug approved under the FDA’s accelerated approval regulations. The drug is sold as ProAmatine by Shire Development Inc., and is also available in generic brands made by other manufacturers. It was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious ... Read More

FDA seeks to shut down Brooklyn food manufacturer for good

The U.S. Department of Justice is seeking to permanently shut down a Brooklyn, New York-based maker of ready-to-eat deli salads, seafood, and cream cheeses. Food and Drug Administration inspectors say that NY Gourmet Salads Inc. has a history of serious non-compliance with federal food safety standards and the presence of potentially deadly bacteria in its processing facilities and foods. The complaint, which also seeks a permanent injunction against the company’s owner and president Leonard Spada, was filed July 30 in the U.S. District Court for the Eastern District of New York. The Justice Department charges the defendant with violating federal ... Read More

Drug used to treat staph infections linked to pneumonia

The Food and Drug Administration (FDA) is warning health care professionals and patients about the potential for developing a type of pneumonia when treated with Cubicin (daptomycin), an intravenous antibacterial drug used to treat MRSA and MSSA, serious difficult-to-treat staph infections of the skin and bloodstream. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms include fever, cough, shortness of breath, and difficulty breathing. If not quickly recognized and appropriately managed, esoinophilic pneumonia may lead to progressive respiratory failure and death. After a review of post-marketing adverse event reports, ... Read More

Whitco stadium lights may fall, pose risk of serious injury or death

The U.S. Consumer Product Safety Commission (CPSC) is reminding the public, school officials, facilities managers, and municipal and public safety officials with Whitco Company LP stadium light poles to have them inspected by a qualified engineer immediately because these 70- to 135-foot, 1- to 4-ton poles can fracture or crack and fall over, posing a risk of serious injury or death to patrons and bystanders from being hit or crushed. The poles could put hundreds of people at risk if they fall toward a crowded stadium or onto a building. CSPC first alerted consumers about the potential risk last August. ... Read More

Infant recliners recalled due to suffocation, head injury risk

The suffocation death of a 4-month-old baby who was using a portable baby recliner in a crib has spurred the Consumer Product Safety Commission (CSPC) and Baby Matters, LLC, to recall 30,000 Nap Nannies. The infant was in her harness and found hanging over the side of the recliner, caught between the Nap Nanny and the crib bumper. At least one other infant has become entrapped while using the Nap Nanny in a crib. That infant was also harnessed, fell over the side of the recliner, and was caught between the product and the side of the crib. He suffered ... Read More

Tylenol, Motrin, Benadryl recall expanded

Another 21 lots of Tylenol, Motrin and Benadryl are being added to a recall originally issued January 2010 by McNeil Consumer Healthcare as a precaution because the company discovered the drugs were shipped in wooden pallets that had been treated with a fungicide and may cause consumers to become ill. The recall was originally initiated because there were reports that some of medicines had an unusual moldy, musty, or mildew-like odor that in some cases was associated with temporary and non-serious gastrointestinal events. The medicines affected by the recall were sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto ... Read More