Drugs

Lupin Recalls 42 Lots of Injectable Ceftriaxone

Lupin Pharmaceuticals has recalled five lots of ceftriaxone for injection (250mg), 10 lots of ceftriaxone for injection (500mg), 24 lots of ceftriaxone for injection (1g) and three lots of ceftriaxone for injection (2g) because the products have been found to contain visual grey particulate matter in reconstituted vials. “Improper piercing and use of a needle greater than 21 gauge (larger internal diameter), while reconstituting the vial, can push rubber flecks into the solution,” a recall notice says. “There were no grey flecks seen prior to the reconstitution of the vials and the issue was identified upon standard visual inspection prior to patient administration.”

The antibiotic is used to reduce the development of drug-resistant bacteria. If injected, this product could cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system, the recall notice says.

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