At the request of the FDA and the U.S. Attorney for the Southern District of Florida, U.S. Marshals seized unapproved prescription drug products valued at over $1,500,000 from Stratus Pharmaceuticals, Inc., of Miami, Florida. Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey. Click title to continue reading...

The FDA is alerting health care practitioners and the public that a counterfeit version of Botox was found in the United States and may have been sold to doctors’ offices and medical clinics nationwide. The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States. Click title to continue reading...

On March 30, 2015, OriGen Biomedical of Austin, TX, initiated a nationwide recall for one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters. These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. OriGen Biomedical is aware of at least one product failure and has received a complaint associated with the problem. This serious adverse event resulted in a patient death. Click title to continue reading...

Current e-cigarette use among middle and high school students tripled from 2013 to 2014, according to data published by the CDC and the FDA’s Center for Tobacco Products. Findings from the 2014 National Youth Tobacco Survey show that current e-cigarette use (use on at least 1 day in the past 30 days) among high school students increased from 4.5 percent in 2013 to 13.4 percent in 2014, rising from approximately 660,000 to 2 million students. Among middle school students, current e-cigarette use more than tripled from 1.1 percent in 2013 to 3.9 percent in 2014—an increase from approximately 120,000 to 450,000 students. Tobacco use and addiction most often begin during youth and young adulthood. Youth use of tobacco in any form is unsafe. Click title to continue reading...

A seven-year-old girl had a fever and sinus congestion. After reading the warning labels on the box and the bottle, her father administered two doses of an over-the-counter (OTC) medication containing ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), as its active ingredient. Click title to continue reading...

A man worked in the information technology division of a company. He assumed a high-pressure job, with responsibility for providing support for the server infrastructure at the company’s locations around the world 24 hours a day, 365 days a year. About 21 months after starting this new position, the man suffered the sudden onset of right side numbness, dizziness, and blurred vision. He was hospitalized and provisionally diagnosed with a stroke. Although this diagnosis could not be confirmed, some of his symptoms persisted and he did not return to work. Click title to continue reading...

A man who had previously suffered a stroke was admitted to a hospital. The nursing staff at the hospital assigned the man a fall risk assessment score of eight. The following day a hospital employee found the man on the floor. He had apparently fallen out of his bed. A subsequent CT scan revealed in acute subarachnoid hemorrhage, which was attributed to left frontal trauma. Click title to continue reading...