Drugs

Drug Recalls Up, Device Recalls Down: Report

The Stericycle Recall Insights report for the third quarter of 2020 shows that drug recalls increased markedly in the quarter while medical device recalls fell to their lowest level in several quarters. The report says that drug recall activity increased by 49.5% in the third quarter, with affected units almost doubling (92.7%). Almost one-quarter of all affected units were considered Class 1 severity, Stericycle says. And some 83% of third-quarter recalled products were distributed nationwide.

The report says that current good manufacturing practice (CGMP) deviations were the leading cause of recalls at 29%. It was the top cause for the fifth time in the last six quarters. Quality concerns edged out CGMP deviations as the top cause in terms of units affected, largely due to one recall of 7.7 million units.

For medical devices, Stericycle reports that third-quarter recalls fell 29% from 341 to 242 events, the lowest number since 2019 quarter three. Total affected units fell 21.9% to 22.9 million, the lowest quarterly number since 2019.

Software issues were the top reason for recalls, accounting for 20.7% of events and 21.4% of units. It was the 17^th time in 18 consecutive quarters that software issues were the leading recall cause.

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