The recall involves a pair of mechanical pumps that help the heart pump blood when it can't do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution w...
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...
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility AssuranceDec 4, 2021 | Audience: Health Professional, Pharmacy December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC ...
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...
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Source: FDA Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility AssuranceDec 4, 2021 | Audience: Health Professional, Pharmacy December 4, 2021 – Colcheste...
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 ...
Based on that testing, FDA requested that identified applicants voluntarily recall these lots of the extended-release metformin. FDA continues to investigate possible NDMA impurities in metformin and other drug products and will advise companies on appropriate action. Because the nitrosamine impurity issue...
FDA Seeking Legal Action In Drug RecallMalcolm Gladwell