Posts Tagged 'FDA'

Dialysis drug recalled after patient death

A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death. The U.S. Food and Drug Administration issued a notice this week of the recall, saying it had received one report of death and two reports of injury that may be related to use of Fresenius NaturaLyte Liquid Bicarbonarte Concentrate. Lab testing identified Halmonas, a bacteria typically found in water with high salt concentration, in the product during its shelf life, the FDA said.

Read more about the Fresenius recall…

$11M in unapproved drugs seized by U.S. Marshals

U.S. Marshals recently seized more than $11 million of unapproved drugs distributed by the Cincinnati-based company Masters Pharmaceuticals Inc, according to the Food and Drug Administration. The unapproved drugs include Pramoxine-HC Otic Drop, Hydrocortisone Acetate Suppositories, as well as Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%.

Read more about the unapproved drugs…

New intrauterine ball device could alleviate Mirena IUD complications

A new form of birth control known as the intrauterine ball (IUB) could improve on intrauterine devices (IUD) by alleviating Mirena IUD complications. More than 70,000 women have issued Mirena complaints to the U.S. Food and Drug Administration (FDA). An estimated 2 million American women use the birth control device.

Read more about the Mirena birth control alternative…

Breast Pump Adapters Recalled

Playtex Manufacturing is voluntarily recalling electric breast pump AC/DC power adapters over concerns of potential electric shock, although there have been no known injuries, the FDA announced Thursday.

Read more about the breast pump recall…

Zithromax side effects make top 10 heart health stories of 2013

The discovery of Zithromax (Z-pak) side effects was the number 3 heart health story of 2013, as chosen by readers of The Food and Drug Administration warned in March 2013 that the popular antibiotic could cause potentially fatal arrhythmias in otherwise healthy patients.

Read more about potential Z-Pak side effects…

German antitrust regulator debating Fresenius hospital purchase

Antitrust regulators in Germany are considering whether or not to allow Fresenius Medical Care’s purchase of Rhoen-Klinikum’s 43 hospitals and 15 outpatient clinics. The regulators will decide by February 2014 if the $4.1 billion transaction violates German laws designed to prevent monopolies.

Read more about the Fresenius hospital purchase…

Judge sets timeline for GranuFlo lawsuit fact sheets

Judge Douglas P. Woodlock has set a timeline for plaintiff fact sheets to be submitted in the bellwether GranuFlo lawsuits. Plaintiffs were required to submit their information by November 27, 2013, and defendants must submit their fact sheets by January 31, 2014.

Read more about the GranuFlo lawsuit timeline…

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