News & Analysis as of

Recall of Blood Thinner Product

Alere Defective Medical Testing Strips Recalled - Are you currently taking a blood thinner to prevent the risk of a stroke, blood clot, or other medical condition? A recent article in Forbes alerted patients that...more

FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

Product Recall Information for Consumers

A recall is the process of addressing defects found in specific products. In most cases, the decision to issue a recall is voluntarily made by the manufacturer of the defective product. However, a government agency can...more

FDA Reports Rise in Medical Device Recalls and Warnings

This news is not surprising to anyone who pays attention to medical device recalls. There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division...more

Why Drug Approval and Recall Systems Leave Patients Vulnerable to Harmful Drugs

The drug is on the market, so it must be safe, right? Although this assumption is entirely reasonable, it is not always true. The FDA approval and recall processes can allow harmful pharmaceuticals to remain on the market...more

What You Need To Know About The Granuflo Recall

In 2012, the Food and Drug Administration recalled Naturalyte and GranuFlo, which are manufactured by Frensenius Medical Care. Naturalyte and GranuFlo are used in the treatment of acute and chronic renal failure during...more

Medtronic Cardiac Guidewire Warning

The procedure to implant a cardiac stent, which keeps blocked arteries open, includes inserting guidewires to move the device into place. Federal health officials have issued a warning about a defect in some Medtronic...more

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

How Naturalyte And Naturalyte Granuflo Were Improperly Administered — And Who Is Responsible

In March 2012, the manufacturer of NaturaLyte Liquid and NaturaLyte Granuflo Acid Concentrates issued a Class 1 recall of the products, which are used in hemodialysis to treat patients with acute and chronic renal failure. ...more

Serious Risks Of Yaz And Related Drospirenone Birth Control Pills Prompt Lawsuit

In 2011, the U.S. Food and Drug Administration began issuing warnings that birth control pills containing drospirenone — including brand names Yaz, Yasmin, Beyaz, Safyral and their generics Gianvi, Loryna, Ocella, Syeda and...more

FDA Flexes Its FSMA Muscles, Initiates Mandatory Recall

Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority. On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more

Understanding FDA Procedures in a Pharmaceutical Recall

News reports are filled with frequent recalls of harmful and dangerous drugs. Many times, companies voluntarily issue a recall after receiving consumer complaints. However, in other situations the Federal Drug Administration...more

FDA Issues Draft Guidance on Medical Device Recalls - How to Distinguish Recalls from Product Enhancements

On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

Spilled Milk: District Court Judge Sides with Policyholder in Recall Damages Dispute

On January 8, 2013, a Minnesota federal district court granted summary judgment in favor of a policyholder who sought coverage from its commercial general liability insurer for contract damages stemming from the recall of...more

President Obama Signs New Expansive Food Safety Law

In the flurry of legislation passed by the 111th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day,...more

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