FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Voluntary Product Recall Initiated by Qualitest Pharmaceuticals Impacts Three Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Repackaged and Distributed by Mylan Institutional
Contact
Consumer:
(800) 848-0462
Media
Nina Devlin
(724) 514-1968
FOR IMMEDIATE RELEASE - December 20, 2012 - Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business is conducting a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573). The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a Mylan Institutional Inc.) label. Qualitest Pharmaceuticals first initiated the recall on Dec. 6, 2012, due to the possibility that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen. As indicated in Qualitest Pharmaceuticals' announcement, unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.
Additional information can be found at http://www.fda.gov/Safety/Recalls/ucm333153.htm. Consumers who have the affected lots can contact Mylan Customer Service with questions at 800.848.0462 on Monday through Friday between 8 a.m. and 5 p.m. EST.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com
Recalls, Market Withdrawals, & Safety Alerts
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Audience: Cardiology, Patients.
ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.
FDA Alert: Reumofan Plus Dietary Supplement Relabeled and Sold as “WOW”: Public Warning - Undeclared Drug Ingredients
Audience: Consumers, Healthcare Professionals.
ISSUE: The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name "WOW." The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. FDA laboratory analysis confirmed that "WOW" contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocrabamol (a muscle relaxant). These ingredients have the potential to cause serious injury.
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In 2009, the American Academy of Environmental Medicine (AAEM) stated that, "Several animal studies indicate serious health risks associated with genetically modified (GM) food," including infertility, immune problems, accelerated aging, faulty insulin regulation, and changes in major organs and the gastrointestinal system. The AAEM has asked physicians to advise all patients to avoid GM foods. [1]
Genetic Roulette - The Gamble of Our Lives (Abridged Movie)
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Water Commission Denies Monsanto Request
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Watch the trailer!
Donate
Watch their most recent collaboration, 9/12: From Chaos to Community, named a “Best Documentary of the Year” by Video Library Magazine.
FDA Alert: Zicam Extreme Congestion Relief Nasal Gel: Recall - Contamination With Burkholderia Cepacia
Audience: Consumer.
ISSUE: Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.
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Mental Health America - My Mood Monitor
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I am pledging to help end the stigma and ignorance that exists with mental health disorders today. I promise to take care of my mental health. I just took Mental Health America’s M3 screener to evaluate myself, and I promise to continue to monitor myself and learn ways I can live a mentally healthier life. Please join me by taking this pledge, the M3 screener (http://bit.ly/NvZAfr), and sharing this post with your friends.
FDA Alert: Libigrow, Libigrow XXXtreme, Blue Diamond . . .
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ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided. The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.
Mental Health in the Headlines: Week of December 17, 2012
Mental Health America: Mental Health in the Headlines: Week of December 17, 2012
Mental Health in the Headlines is a weekly newsletter providing the latest developments at Mental Health America and summaries of news, views and research in the mental health field. Coverage of news items in this publication does not represent Mental Health America's support for or opposition to the stories summarized or the views they express.
[NOTE: Mental Health in the Headlines will not publish the weeks of December 24 and December 31. Our next issue will be January 7, 2013.]
TODAY'S HEADLINE
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People taking the antidepressant Wellbutrin now have one less option for a generic version of the drug.
In October, the U.S. Food and Drug Administration recommended that generic Wellbutrin, or bupropion, made by Impax Laboratories and distributed by Teva Pharmaceuticals, be taken off the market, and Impax and Teva have agreed to stop shipping the drug. Read more...
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Intestinal Candidiasis a.k.a. Yeast Syndrome
Could A Yeast Overgrowth Be The Cause?
I’ve learned that I have an overgrowth of candida yeast, intestinal candidiasisor yeast syndrome, which could be in part why I have been experiencing chronic pain. So, I have been recommended to go on a candida diet. I wanted to share what I have been given with my followers. I hope to start on this diet sometime this week. Two to four weeks is what is suggested for how long to stay on this diet. I’m looking at doing this for two weeks. I will update on the results!
There are literally trillions of bacteria living in our digestive tract, making up the normal “micro flora.” These bacteria generally play a supportive role in the health of the colon by helping to synthesize vitamins, degrade toxins, and produce natural antibiotics. Candida, a yeast-like fungus, also normally inhabits the gut in small amounts. However, if these yeast organisms are allowed to grow unchecked, the harmonious balance between yeast and bacteria is upset, resulting in intestinal candidiasis or what has been called the yeast syndrome. Not only can this overgrowth cause problems such as vaginal infections and oral thrush, but also candida can release byproducts, which are then absorbed into the bloodstream and may travel to many areas of the body. A variety of symptoms may then occur as the immune system attempts to deal with these foreign molecules. As a result, intestinal candidiasiscan be an underlying cause of chronic, difficult to diagnose health problems. Below is a list of symptoms that may be associated with yeast overgrowth.
Common Symptoms of the Yeast Syndrome
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Click here for the Candida Control Diet
For more detailed information about the connection between chronic illnesses and yeast overgrowth, read The Yeast Connection and The Yeast Connection Handbook by Dr. William Crook.
For helpful resources, including access to charts and forms, please visit www.yeastconnection.com.
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