Safety Alerts & Recalls

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FDA to review studies showing higher blood clot risk from drospirenone
The Food and Drug Administration (FDA) has said it is conducting a safety review of certain types of birth control pills containing drospirenone to see whether they increase the risk of blood clots more than that of other pills. Examples of brand name birth control pills containing drospirenone include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah. All birth control pills pose a risk of blood clots. Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported an increase in risk. The FDA will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills and will notify the public when new safety information becomes available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm257164.htm To read the FDA's Question and Answer website about this safety issue, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257175.htm
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Teva Pharmaceuticals USA. Recalls Single Lot of Fexofenadine Hydrochloride Tablets USP, 180 mg
Teva Pharmaceuticals USA has recalled a single lot of Fexofenadine Hydrochloride Tablets USP, 180 mg. Lot number 26F109 is being recalled because this lot did not meet the Food and Drug Adminstration’s (FDA) standards for testing and quality during manufacturing. Fexofenadine is used in the treatment of allergies. Fexofenadine is also sold under the brand name Allegra. No other lots, strengths, or brands of Fexofenadine were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm253935.htm
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Date Published Title Drug Source
2011-05-31 FDA to review studies showing higher blood clot risk from drospirenone Drospirenone with Ethinyl Estradiol FDA
2011-05-27 Teva Pharmaceuticals USA. Recalls Single Lot of Fexofenadine Hydrochloride Tablets USP, 180 mg Fexofenadine FDA
2011-05-26 FDA Conducting a Safety Review of Revlimid and Risk of Developing Another Primary Cancer Lenalidomide FDA
2011-05-26 FDA Issues Statement on the AIM-HIGH Trial Niacin FDA
2011-05-26 Regrowth LLC Recalls Several Lots of Retinoic Acid, Minoxidil, and Spironolactone Topical Solution Tretinoin FDA
2011-05-26 Pfizer Pharmaceuticals LLC. Recalls Single Lot of Aldactone (spironoloactone) tablets USP 50 mg Spironolactone FDA
2011-05-20 Coloplast Manufacturing US Recalls Select Lots of Critic-Aid Skin Paste 2.5 oz/71g Petrolatum and Zinc Oxide FDA
2011-05-20 Novartis Pharmaceuticals Corp. Recalls Single Lot of Valturna (aliskiren and valsartan) Tablets 300 mg/320 mg Aliskiren and Valsartan FDA
2011-05-20 Teva Pharmaceuticals Recalls Single Lot of Metformin Hydrochloride Tablets, USP 500 mg Metformin FDA
2011-05-20 Teva Pharmaceuticals Recalls Several Lots of Simvastatin Tablets USP, 20 mg and 80 mg Simvastatin FDA
2011-05-19 Avandia, Avandamet, and Avandaryl Soon to Be Available Only Through Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2011-05-11 Multi-Mex Distributor Inc. Announces Recall of Dietary Supplements Amoxicillin FDA
2011-05-06 FDA Provides Guidance for Dispensing Devices and Drugmakers Remove OTC Infant Acetaminophen Drops FDA
2011-05-06 Benefits of Bisphosphonates Continue to Outweigh Risks Ibandronate Sodium MediGuard CRT
2011-05-02 Bristol-Myers Squibb Recalls Coumadin 5 mg Tablets Warfarin Manufacturer
2011-05-02 Novartis Pharmaceuticals Recalls Single Lot of Foradil Aerolizer (formoterol fumerate inhalation powder), 12 mcg Formoterol FDA
2011-05-02 Aurobindo Pharmaceuticals Recalls Several Lots of Mirtazapine Tablets, 45 mg Mirtazapine FDA
2011-05-02 Abbott Laboratories Recalls Select Lots of Humira (adalimumab) Pen, 40 mg/0.8mL Adalimumab FDA
2011-05-02 UDL Laboratories, Inc. Recalls Single Lot of Levothyroxine Sodium Tablets, 150 mcg Levothyroxine FDA
2011-05-02 Teva Recalls Single Lot of Chlorzoxazone Tablets, 500 mg Chlorzoxazone FDA