Drugs

SterRx Recalls 240 Drug Lots Over Sterility

SterRx has recalled 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance. To date, SterRx has not received reports of any product complaints or adverse events associated with the issue. Affected products are:

lmg/ml midazolam in 0.9% sodium chloride
fentanyl in 0.9% sodium chloride
lmg/ml morphine sulfate in 0.9% sodium chloride
lmg/ml morphine sulfate in 5% dextrose
125mg diltiazem hcl in 0.7% sodium chloride
125mg diltiazem hcl in 5% dextrose
norepinephrine in 0.9% sodium chloride
norepinephrine in 5% dextrose
epinephrine in 0.9% sodium chloride
phenylephrine in 0.9% sodium chloride
150meq sodium bicarbonate in 5% dextrose
200mg succinylcholine chloride in 0.9% sodium chloride

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