Tagged Articles

Inc. 18 articles

Heartware recalls HVAD pump controllers after recalling HVAD pumps

A week after Heartware, Inc., announced a recall of HVAD pumps, the company announced it is recalling the HVAD pump controllers. HVAD pumps are devices are used to pump blood through the bodies of deathly ill patients with end-stage ventricular heat failure awaiting a heart transplant. The initial recall was issued due to the risk of contamination that could lead to electrical issues that could cause the pump to malfunction or stop working. The latest recall involves a loose power connector in the controller that may cause the rear portion of the pump’s driveline connector to become separated from the front portion ... Read More

FDA warns skin care maker over health claims

The Food and Drug Administration (FDA) blasted Ageless Aesthetics, Inc., a manufacturer of skin care products, for marketing its products online as treatments that can target age spots and freckles, protect against UV damage, and stimulate the production of collagen and elastin. The FDA found these claims establish the products as drugs under the Federal Food, Drug, and Cosmetic Act, “because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.” As drugs, the products are required to undergo rigorous clinical testing and FDA review before they can be marketed. The agency cited the following ... Read More

FDA approves low-dose, low-cost version of diet pill phentermine

The prescription diet pill phentermine hydrochloride is now available in a low-cost, low-dose form that can be taken up to three times daily. The new 8 mg tablet is manufactured by KVK Tech, Inc., and will be sold under the band name Lomaira. Lomaira is indicated for weight reduction in adults with an initial body mass index (BMI) of 30 or more (obese) or 27 or more (overweight) with at least one weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol. It is intended to be used along with regular exercise and a reduced-calorie diet. Lomaira’s 8 mg ... Read More

FDA investigating whether dietary supplements contain unapproved drug

The Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) is investigating whether dietary supplement makers are illegally adding to their products an experimental drug being tested to treat muscle wasting in cancer patients undergoing chemotherapy. The drug Ostarine, known chemically as endobosarm, is in a class of drugs known as selective androgen receptor modular (SARM) and is being tested in patients by Memphis, Tenn.-based GTX, Inc. While no SARMs are currently on the market, they have been used by athletes to assist in training because they are thought to increase physical stamina and fitness similar to anabolic steroids. ... Read More

Tainted dietary supplements for male sexual enhancement recalled

SOS Telecom, Inc. is recalling all lots of dietary supplements marketed for male sexual enhancement because the products were found to contain sildenafil, the active ingredient in the erectile dysfunction medication Viagra. The dietary supplements do not disclose on the products’ labels that they contain sildenafil, and the company is not authorized to market the medication. The undeclared ingredient was found in SOS Telecom’s dietary supplements during routine testing by the Food and Drug Administration (FDA). Affected products include the following: Tiger-X (Lot No: 9236999; Best use by: 12/16/2016): 1 capsules per pack / 24 single packs per box. Ninja-X ... Read More

Lawsuits Against Makers of Defective Retrievable IVC Filters Consolidated to Southern District of Indiana

Lawsuits against Cook Medical, Inc., the maker of the retrievable IVC filter known for its allegedly defective design have been consolidated to Southern District of Indiana in a multidistrict litigation (MDL). The IVC filter is a cage-like device that is implanted into the largest vein of the body – the inferior vena cava – and is designed to catch blood clots, preventing them from entering the heart and/or lungs, resulting in pulmonary embolism. Retrievable designs, such as Cook’s Gunther Tulip or Celect filters, are intended to be used for a short period of time, then removed. They are often used in ... Read More

Meningitis treatment recalled due to impurity risk

Sagent Pharmaceuticals, Inc., is recalling one lot of Fluconazole injection used to treat oropharyngeal and esophageal candidiasis, cryptococcal meningitis, due to an impurity that can decrease the effectiveness of the product in patients. The impurity was identified as the antibiotic Metronidazole, and patients treated with this product who are already taking Metronidazole may receive an increased dose of the drug. Metronidazole is used to treat various infections, including certain types of vaginal infections. It can also treat skin redness and pimples caused by rosacea. The issue was identified during routine quality testing of stability samples at the 18-month interval. The recall involves ... Read More

Compounding pharmacy recalls products due to mold contamination

Med Prep Consulting, Inc., a compounding pharmacy based in Tinton Falls, NJ, is recalling all products after mold was discovered floating in plastic infusion bags. The mold was discovered in five bags of magnesium sulfate 2GM in Dextrose 5% in water, 50ml for injection, a product used for magnesium electrolyte replacement. If an intravenous product found to contain mold is injected into a patient, it could have deadly results. In an abundance of caution, Med Prep Consulting has recalled all products compounded by the pharmacy due to lack of sterility assurance. The affected products are administered for a wide range ... Read More

Gas tanks for dental procedures recalled due to potentially deadly defect

Accutron, Inc. is recalling some of its gas tanks used to deliver nitrous oxide-oxygen to sedate patients during dental procedures because of two customer reports that the flowmeter on the tank was flowing nitrous oxide without any oxygen gas flow. When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death. There have been no injury reports to date. Accutron issued the recall on eight models of the Ultra PC% Cabinet Mount Flowmeter, which includes 206 units. The gas tanks were manufactured from November 2009 to April 2009 and distributed from November 26, ... Read More

Whose Gardasil study is this, anyway?

The results of a recently completed study were reported in USA Today on Jan. 28, which definitively declared that the HPV vaccine Gardasil does not trigger autoimmune disorders. The research was conducted in the wake of  public outcry and concern after thousands of reports were filed with the Center for Disease Control’s Vaccine Adverse Event Reporting System (VAERS) indicating young girls were suffering serious side effects – and even death – after receiving one or more of the vaccine’s series of three shots. What a relief, right? Not so fast. Later in the article, the reader learns the research was ... Read More