According to the FDA's recall notice, the devices can cause buildup of "biological material" that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient's ch...
The Food and Drug Administration (FDA) has to recall (召回) hundreds of foods every year. Like cookie snack packs with pieces of blue plastic hiding inside, dressing and sauce containing salmonella (沙门氏菌) or various jams containing with lead (铅). It can take a few months before a ...
The FDA is expanding a recall of a popular blood pressure drug over concern it may contain an unwanted ingredient that can cause cancer. Aurobindo Pharma says it is voluntarily recalling tablets with the ingredient valsartan because it found trace amounts of a substance known as NDEA. Reca...
2022 FDA Drug Approval List, 2022 Biological Approvals and Approved Cellular and Gene Therapy Products Posted in cell-based therapy, Drug Discovery Chemistry, FDA, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Pharmaceutical Discovery, ...
can be conducted on a firm’s own initiative, by FDA request, or by FDA order. Although the FDA has the authority to recall biologics (products made of human cells or tissues like vaccines), devices and infant formulas, it does not have the authority to order or mandate a drug recall....
The US Food and Drug Administration will soon become the latest agency to make its work more accessible to the public. The Regulatory Affairs Professionals Societypoints outthat in January, the FDA added a page for "openFDA," a project to organize and release data sets. This summer, the agen...
market. See the list of valsartan products under recall and the list of irbesartan products under recall. Drug products that contain NDMA or NDEA above the limits in the table below pose an unacceptable risk to patients. The agency will use the interim limits to recommend manufacturers conduct ...
We further acknowledge your decision to recall all drug products that you repackaged into heat-sealed pouches with one transparent side instead of a light-resistant container closure system. 我们进一步确认,知晓您决定召回所有含透明面包装的热封袋药品(非耐光容器封闭系统)。
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Source: FDA Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength Oct 15, 2015 | Audience: Pharmacy, Consumer
The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific updated […] Filed Under: Cardiovascular, Catheters, Food & Drug Administration (FDA), Pulsed-Field Ablation (PFA), Recalls, Regulatory/Compliance Tagged With: Boston ...