Drugs

Drug, Medical Device Recalls Up in 1st Quarter

Drug recalls surged by 53.2% from 94 in the fourth quarter of 2022 to 144 in the first quarter of 2023, according to the Sedgwick first quarter recall index. The report says current good manufacturing practice deviations dominated the recall activity, accounting for 70 events and 33.2 million affected units in the first quarter. Failed specifications were the second most common cause for both recall events and units affected. Sterility was the third most common cause.

“Total impacted units rocketed 1,071.8% from 4.2 million in the fourth quarter to 49.5 million,” Sedgwick says.

For medical devices, the report shows that recalls increased 4.6% in quarter one, from 241 events in quarter four of 2022 to 252 in the first quarter of 2023. Manufacturing defects were the leading cause, accounting for 59 events (23.4%). Total affected units were up 34.3% from 62 million in the fourth quarter of 2022 to 83.3 million.

The number of Class 1 recalls for medical devices decreased to 14, compared to 18 in the previous quarter, Sedgwick reports. However, the number of Class 1 units affected surged to 66.97 million in the first quarter, compared to 3.02 million in the fourth quarter of 2022.

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