The FDA Recalls section of PA-Law-Blogs discusses recent consumer product recalls issued nationwide by the Department of Health and Human Services’ Food and Drug Administration (FDA). In providing the most up-to-date FDA recall news and information, PA-Law-Blogs also covers class action and mass torts product liability and consumer protection matters related to the Pennsylvania cities of Philadelphia, Harrisburg, Pittsburgh, Allentown, Reading, Bethlehem, Scranton, Erie, and York… read more
Archive for the ‘FDA Recalls’ Category
FDA Widening McNeil Drug Recall Investigation
The U.S. Food and Drug Administration (FDA) is investigating reports of at least 775 cases of adverse side effects from drugs that were recalled by McNeil. According to a Fox News report, these serious side effects included death. FDA officials are investigating seven fatalities since the May 1 recall of a number of children’s medications [...]
Philadelphia Avandia Lawsuits Settled by Glaxo
GlaxoSmithKline Plc has settled thousands of pharmaceutical lawsuits brought by patients who are saying that the drug maker’s diabetes drug, Avandia, has caused heart attacks. According to a Reuters news report, consolidated Avandia lawsuits in Philadelphia that had been due to come to court this month have all been settled. Company officials said that the [...]
Drug Contamination Leads to FDA Recall
Pharmaceutical drugs have the power to cure or mitigate the symptoms of many illnesses and chronic diseases. They can result in a tremendous improvement of quality of life. However, quality control is a crucial part of drug manufacturing. The chemicals and ingredients that go into these medications are potent and must be combined with precision. [...]
FDA to Decide on Approval of Prostate Cancer Vaccine
Vaccine and various other pharmaceutical manufacturers must conduct several tests and invest a substantial amount of money and time before the U.S. Food and Drug Administration (FDA) approves their product for patient and consumer use. A prostate-cancer vaccine, Provenge, has been 20 years in the making. If approved by the FDA, Provenge would represent a [...]
FDA Warning Letters – Drug Contamination and Manufacturing Defects
When a drug manufacturing company issues its second pharmaceutical recall within a span of six months, a real solution to prevent manufacturing defects and contamination must be established. The first step in making sure that such reform takes place is not only through a recall, but also an FDA warning letter, which is supposed to [...]
Asthma Drugs Could Cause Sudden Fatal Asthma Attacks
If you have asthma, you should be checking your labels and possibly limiting your prescription use, especially in particular combinations. The FDA has issued warnings that people with asthma should not use the medications Foradil and Serevent alone, and the usage of Symbicort and Advair in combination with each other should be limited. The reason [...]
Backlogged FDA: Will More Scientists Shrink Backlog of Applications?
The FDA has dipped into the $10 million allocated to the Office of Generic Drugs for this fiscal year to hire 50 more scientists in hopes of shrinking the backlog of around 2,000 applications that are already awaiting review.
Should the FDA Deem Tobacco Lozenges a “Modified Risk” Product
Star Scientific Inc. is asking the FDA to certify its tobacco products as less harmful than other tobacco products. Star Scientific sells tobacco lozenges that dissolve in your mouth, and they have asked the FDA to approve the lozenges as a product that is a “modified risk” commodity. The Virginia-based company claims that the levels [...]
New FDA Rules Could Change Product Liability, Consumer Protections
The U.S. Food and Drug Administration is taking a close look at how it handles approval for medical devices in today’s fast-paced medical industry. A Feb. 19 report in the Insurance Journal shows that FDA staff is saying they need to change the rules on approval for different kinds of medical devices, which may lead [...]
FDA Labeling: Friend or Foe?
The application for FDA approval is usually about 100,000 pages long. According to the FDA, the label is required to provide necessary information about a particular drug. This includes how the drug is effective, potential risks, and how to use it. However, FDA officials recently suggested that the diabetes medication, Avandia, should be pulled off [...]