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FDA recall 64 articles

RegenESlim appetite control capsules recalled due presence of dangerous ingredient

Certain lots of RegenESlim appetite control dietary supplements are being recalled because they contain an ingredient that may cause deadly side effects. A Food and Drug Administration (FDA) analysis found in two lots of RegenESlim the presence of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, commonly used as a stimulant, pre-workout, and weight loss ingredient in supplements. The agency has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, ... Read More

Hospira recalls infusion pump docking stations due to defect that may cause life threatening delay in therapy

Hospira Inc., is initiating a nationwide recall of the GemStarDocking Station, used in conjunction with the GemStar infusion pump, due to a defect that could lead to a delay in therapy, which could cause serious health consequences including death. Infusion pumps are used to deliver medicine and nutrients to patients in a controlled manner. The recall affects the GemStar Docking Station with the list number 13075. When the device is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to ... Read More

Abbott, Hospira infusion pumps recalled due to defect that may result in over-infusion, delay in therapy

Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps used to deliver fluids such as medicine and nutrients into a patient’s body in a controlled manner are being recalled due to reports that the doors on the machines do not close. This can cause an over-infusion or a delay in therapy, both of which can cause serious adverse health consequences, including death. Hospira received reports of broken door assemblies on the Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to ... Read More

Baxter infusions pumps recalled after 3,500 incident reports

Baxter Healthcare is recalling its Sigma Spectrum Infusion Pumps after receiving 3,500 reports of system error incidents in which the device has malfunctioned resulting in nine adverse events. Infusion pumps are designed to deliver fluids such as nutrients or medication into a patients’ body in a controlled manner. A malfunction can result in a delay in therapy, which can lead to serious health consequences including death. The recall affects Baxter Healthcare’s Sigma Spectrum Infusion Pumps with Master Drug Library, models 35700BAX and 35700ABB. The incident reports involve a System Error 322 “Link Switch Error (low),” which occurs when the pump improperly ... Read More

Alli weight loss pills recalled due to potential tampering

GlaxoSmithKline (GSK) is recalling all of its Alli weight loss products in the United States and Puerto Rico after numerous reports across several states that packages may have been tampered with and may contain counterfeit pills. GSK received reports from customers in seven states that bottles of Alli tablets and capsules were not Alli. The counterfeit pills inside the bottles were in various shapes and colors. Some of the bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. All of the tampered with products were purchased in retail stores. Alli is an over-the-counter ... Read More

Playtex recalls breast pump power adapter due to potential electric shock hazard

Playtex Manufacturing is recalling some of the AC/DC power adapters used with its Playtex Nurser Deluxe Double Electric Breast Pump because the casings may come loose and separate, which could cause electric shock. No injuries have been reported to date. The company says the recall is being taken out of an abundance of caution. The affected adapters were manufactured from November 2012 through July 2013, and can be identified by the serial number P12324-XXXX through P13205-XXXX, as well as by the adapter production codes 1241 through 1324. The adapters were not sold individually, but were included with the Playtex Nurser ... Read More

Abbott recalls FreeStyle, FreeStyle Flash blood glucose meters

Abbott’s FreeStyle and FreeStyle Flash blood glucose meters are being recalled because when used with the Abbott FreeStyle test strips the meters may produce mistakenly low blood glucose results. Both the FreeStyle and the FreeStyle Flash meters have been in production since 2010. Blood glucose meters are used to measure blood sugar levels in diabetic patients. Those who have the meters affected by this recall should immediately contact Abbott Diabetes Care at 1-888-345-5364 to receive a replacement meter. Consumers who have access to an alternative glucose meter should immediately discontinue using their Freestyle or FreeStyle Flash meter and take the necessary ... Read More

Reports of death, infection prompt recall of SafeSpout, SafeShower water filtration systems

The Food and Drug Administration (FDA) has ordered a Class 1 recall following a death and an infection linked to Nephros-brand non-medical water filtration systems. SafeSpout and SafeShower products can expose users to harmful bacteria or viruses when the fiber filter or the sealing compound holding the filter in place breaks apart. This can cause serious infections and death. A Class 1 recall is the most serious recall and involves situations in which there is a reasonable probability that use or exposure to the product will cause serious adverse health consequences or death. SafeSpout and SafeShower products are designed to filter ... Read More

Fresenius asks Missouri officials to send back drug it intended to use for executions

Fresenius Kabi, one of four business segments of the worldwide dialysis giant Fresenius Medical Care, is playing hardball with one of its U.S. wholesalers for mistakenly selling its anesthetic propofol to the state of Missouri, which purchased it for use in executions. German drug maker Fresenius made its wholesalers sign contracts agreeing they wouldn’t sell the drug to states for use in executions. The death penalty is not practiced in Europe, and Germany has a law that does not allow the export of medications for such uses. Fresenius was being pressured not to sell propofal in the United States because of the ... Read More

Illnesses prompt another recall of compounding pharmacy products due to sterility concerns

All sterile products made and distributed by a Dallas-based compounding pharmacy are being recalled after an inspection of the facility uncovered poor sterile production practices. The inspection occurred after the Food and Drug Administration (FDA) received reports of fever, flu-like symptoms and soreness at the injection site in patients who received one of the company’s products. The recall affects all sterile products made by NuVision Pharmacy. The adverse events were associated with methylcobalamin injection, which is a form of vitamin B12 supplementation used to treat people with pernicious anemia, those suffering from a temporary B12 deficiency and a symptom of ... Read More