Drugs

Baxter Recall Leaking IV Solutions

Baxter International has recalled four lots of intravenous (IV) solutions due to the potential for leaking containers and particulate matter. The company says it became aware of the problems after receiving two complaints for leaking containers and one complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events reported to date.

Leaking containers could result in product contamination, Baxter says, adding that it could lead to a bloodstream infection, worsened patient condition or other serious adverse health consequences. “Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vesselsg, which can result in stroke, heart attack, damage to other organs such as the kidney or liver, or death,” it says.

The affected products are: 9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container - lot # P337857 9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container - lot # P328997 Metronidazole Injection, USP 500mg/100mL - lot # P339135 Clinimix E 5/15 (5% AA w/Electrolytes in 15% Dextrose w/Calcium) - lot #P333930

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

Read more

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