Safety Alerts & Recalls

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Apotex Corp Recalls Single Lot of Oxybutynin Oral Solution
Apotex Corp has recalled a single lot of Oxybutynin Chloride Oral Solution, 5 mg/mL. Lot number HV7148 has been recalled because the solution may be different in color. Oxybutynin chloride is used in the treatment of overactive bladder. Oxybutynin chloride is also sold under the brand name Ditropan, Ditropan XL, Gelnique, and Oxytrol. Oxybutynin is sold in other formulations such as tablets and patches. No other lots, strengths, formulations, or brands of oxybutynin chloride were involved in this recall. To view the FDA notice about this recall, please visit http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm229271.htm
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Fresenius Recalls Single Lot of PhosLo GelCaps
Fresenius Medical Care Holdings, Inc. and Braintree Laboratories Inc have recalled a single lot of PhosLo GelCap 667 mg. Lot number 1308035 has been recalled because this lot failed the manufacturer routine tests that measure the gelcaps' ability to dissolve. PhosLo GelCaps contain the active ingredient calcium acetate and are commonly used in the treatment of high phosphate levels in the blood in end stage kidney disease. This recall alert only applies to the single lot of PhosLo (calcium acetate), 667 mg GelCaps. No other calcium acetate products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm229271.htm
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Date Published Title Drug Source
2010-10-27 Apotex Corp Recalls Single Lot of Oxybutynin Oral Solution Oxybutynin FDA
2010-10-27 Fresenius Recalls Single Lot of PhosLo GelCaps Calcium Acetate FDA
2010-10-27 Teva Recalls a Single Lot of Claravis Capsules Isotretinoin FDA
2010-10-27 American Health Packaging Recalls Single Lot of Dronabinol Capsules Dronabinol FDA
2010-10-22 Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/hr Fentanyl Manufacturer
2010-10-21 Warnings of Risk of Abnormal Heart Rhythm Added to Prescribing Information for Invirase Saquinavir FDA
2010-10-21 New Safety Warnings Added to Gonadotropin-Releasing Hormone (GnRH) Agonists Lupron FDA
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Angeliq MediGuard CRT
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Estrogens Conjugated with Medroxyprogesterone MediGuard CRT
2010-10-19 McNeil Consumer Healthcare Recalls Single Lot of Tylenol 8 Hour Caplets Acetaminophen Manufacturer
2010-10-15 FDA Provides Answers to Common Questions About Unapproved Chelation Products FDA
2010-10-13 FDA Updates Prescribing Information to Warn of Possible Fracture Risk With Osteoporosis Drugs Ibandronate Sodium FDA
2010-10-10 Pfizer Recalls Several Bottles of Lipitor Because of Strange Smell Atorvastatin Manufacturer
2010-10-08 Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia Sibutramine FDA
2010-10-04 Bristol-Myers Squibb Co. is Recalling 60 Million Tablets of Avalide Hydrochlorothiazide with Irbesartan Manufacturer
2010-10-01 Withdrawal of Unapproved Oral Colchicine Products Colchicine FDA
2010-09-28 Manufacturer Withdraws All Lots of Octagam FDA
2010-09-27 Abbott Voluntarily Recalls Certain Similac Brand Powder Infant Formulas That Did Not Meet Quality Standards Manufacturer
2010-09-24 Amgen Issues Epogen/Procrit Voluntary Recall: Glass Flakes Found in VIals Epoetin Alfa Manufacturer
2010-09-23 Avandia: Restricted Access Program To Be Developed Glimepiride and Rosiglitazone FDA
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