Archive for July, 2011
Potential for Centrifuge bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge, which may result in serious personal injury and damage to the surrounding area.
Tags: MedWatch Safety Alerts
Incurin is indicated for the control of estrogen-responsive urinary incontinence in ovariohysterectomized (spayed) female dogs.
Tags: pet product recalls
Symptoms may include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.
Tags: MedWatch Safety Alerts
Symptoms may include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.
Tags: MedWatch Safety Alerts
On July 28, FDA will host an online session about the agency’s plans to address the increased use of medical devices in the home.
Tags: Consumer Health Alerts
The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
Tags: fda press release
FDA warns consumers about a wart and mole remover that can cause severe skin burns, an unapproved drug sold as a “sexual enhancer,” a diabetes medicine that carries an increased risk of bladder cancer, and more.
Tags: Consumer Health Alerts
The FDA is taking steps to protect the public following the identification of Salmonella Agona in Agromod Produce, Inc.’s supply of fresh papayas. The FDA is advising consumers not to eat papayas from Agromod Produce, Inc. The company is voluntarily recalling the product. The papayas were imported from Mexico, and may be linked to the reported cases of Salmonella Agona. Recent sampling by the FDA found the outbreak strain in two papaya samples: one collected at the Agromod Produce, Inc. location in McAllen, Texas, and one collected at the U.S. border destined for Agromod Produce, Inc. The shipments that tested positive with the outbreak strain were not distributed in the U.S.
Tags: fda press release
A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and contributions to the development of agency regulatory science efforts.
Tags: fda press release
Agromod Produce, Inc. of McAllen, Texas is recalling all Papayas, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Tags: food safety