Drugs

Sagent Recalls Antibiotic Due to ‘Particulate Matter’

Sagent Pharmaceuticals has recalled one lot of oxacillin for injection 10g (lot OXT512 — expiry 3/2017), which was manufactured by Astral SteriTech, due to a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide, a recall notice says. “In the event that metal particulate in an injectable product is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels,” it says. “Blockage of blood vessels can lead to serious events, which may be life-threatening, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.” To date, Sagent says it has not received any adverse patient events resulting from the use of the subject product lot. Oxacillin is indicated for treating infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug.

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