Safety Alerts & Recalls

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Latest Alerts

FDA Warns: Healthy Life Chemistry By Purity First B-50 Contains Possibly Harmful Anabolic Steroids
The Food and Drug Administration (FDA) is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, a vitamin B dietary supplement. The FDA found that this product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement. Healthy Life Chemistry By Purity First B-50 is manufactured by Mira Health Products Ltd. in Farmingdale, N.Y., and is sold on various websites and in retail stores. The company has declined to voluntarily recall the product or to warn consumers about the potential for injury. The FDA has received reports of 29 adverse events associated with the use of Healthy Life Chemistry By Purity First B-50. These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. Women who used this product reported unusual hair growth and missed menstruation, and men who used the product reported impotence and findings of low testosterone. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362800.htm?source=govdelivery
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FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use
The Food and Drug Administration (FDA) recently announced that it is taking several actions related to ketoconazole (Nizoral) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. The FDA has approved changes to the prescribing information and has added a new Medication Guide to address these safety issues. In light of these warnings and limits to use, the FDA recommends ketoconazole oral tablets should not be the first treatment you receive for any fungal infection. Ketoconazole should only be used for the treatment of certain fungal infections, known as endemic mycoses, and even then, only when other antifungal treatments are not available or if they cause too many side effects. The topical forms of ketoconazole (Extina, Xolegel, Nizoral) have not been associated with liver damage, adrenal problems, or drug interactions. These forms include creams, shampoos, foams, and gels applied to the skin, unlike the ketoconazole tablets, which are taken by mouth. There are no changes to the prescribing information for the topical formulations of ketoconazole. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm362415.htm
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Date Published Title Drug Source
2013-07-29 FDA Warns: Healthy Life Chemistry By Purity First B-50 Contains Possibly Harmful Anabolic Steroids Vitamin B Complex FDA
2013-07-29 FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use Ketoconazole FDA
2013-07-08 Sandoz Announces Voluntary Recall of One Lot of Estarylla Ethinylestradiol with Norgestimate FDA
2013-07-03 FDA Updates Prescribing Information for Blood Pressure Medicine Olmesartan to Include Link to Intestinal Problems (Sprue-Like Enteropathy) Hydrochlorothiazide, Amlodipine, and Olmesartan FDA
2013-06-20 One Lot of Rugby Labeled Enteric Coated Aspirin 81 mg Tablets Recalled - May Contain Acetaminophen 500 mg Tablets Aspirin FDA
2013-06-19 FDA Investigates Reports of Two Deaths Following Injections of Zyprexa Relprevv (Olanzapine Pamoate) Olanzapine FDA
2013-06-13 Zydus Pharmaceuticals Recalls One Lot of Warfarin 2 mg Tablets Warfarin FDA
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer Ipratropium FDA
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer and Asthmanefrin Starter Kit FDA
2013-05-29 The Last of the CFC-Containing Inhalers To Be Taken Off the Market Maxair FDA
2013-05-29 L. Perrigo Co. Recalls Select Lots of Liothyronine Sodium Tablets, 5 mcg Liothyronine FDA
2013-05-24 Physicians Total Care Recalls Single Lot of Plavix 75 mg Clopidogrel FDA
2013-05-24 Recall of Levoxyl Produces Medication Shortage Levothyroxine Manufacturer
2013-05-07 FDA Warns Pregnant Women to Not Use Certain Migraine Prevention Medicines Divalproex Sodium FDA
2013-05-01 FDA Updates Prescribing Information for Samsca: Limits Use Tolvaptan FDA
2013-04-29 Anti-Seizure Medicine Potiga (Ezogabine) Linked to Eye Problems and Blue Skin Discoloration Ezogabine FDA
2013-04-26 Saratoga Therapeutics, LLC Recalls ebA Multivitamin Supplement Due to Undeclared Milk Components Multivitamin FDA
2013-04-19 One Touch Verio IQ and FreeStyle lnsulinx Blood Glucose Meters Recalled Insulin Lispro and Insulin Lispro Protamine FDA
2013-04-01 FDA Allows Changes to the Warnings and Directions for Use of Nicotine Patches, Gum, and Lozenges Nicotine FDA
2013-03-15 FDA Studies Possible Pancreatic Risk With Class of Diabetes Drugs Sitagliptin FDA