Drugs

Baxter Recalls Intralipid Lot Due to Subfreezing Storage

Baxter International has recalled one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100 mL, distributed between 8/11 and 8/31 to hospitals and healthcare providers in the U.S. The product was exposed to subfreezing temperatures during transit to a distribution facility, a recall notice says, adding that subfreezing temperature is outside of the acceptable storage range. “If accidentally frozen, Intralipid 20% IV Fat Emulsion should not be used,” it says. “When subjected to freezing, the emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation and lead to serious adverse health consequences that can be life-threatening.” The product is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome