Drugs

Braun Recalls 2 Sodium Chloride Lots

Braun Medical has recalled (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate matter in the drug container and fluid leakage. “The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage,” a recall notice says. To date, the company says there have been no customer complaints received and no serious injury reports associated with the issue.

The notice says there is the probability of “embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile.” It adds that such problems could lead to permanent damage or impairment of body function, which could be life-threatening.

The intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. It is also indicated for use in a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.

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