Safety Alerts & Recalls

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FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ
US Marshals recently seized more than $11 million worth of unapproved products marketed by Ascend Laboratories of Montvale, NJ, and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The seized products included: - Pramoxine-HC Otic Drops, intended to treat infections of the external ear and control itching - Hydrocortisone Acetate Suppositories 25 milligrams (mg), intended to treat inflamed hemorrhoids, ulcerative colitis, and other inflammatory conditions - Urea Cream 39%, Urea Cream 40%, and Urea Lotion 40%, intended to treat skin-thickening conditions such as dermatitis and eczema. The US Food and Drug Administration (FDA) requested the seizure because these products were being marketed without having been proven safe or effective for their intended uses. These unapproved products may be of uncertain quality and do not have FDA-approved labeling. As a result, these drugs may pose risks to patients. For more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm397653.htm
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Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips
Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ BMB-BA006A blood glucose test strips manufactured by a company named BroadMaster Bio-Tech Corp. These strips have been recalled because of a labeling error. There could be some confusion about which glucose meters the Redi-Code+ BMB-BA006A blood glucose test strips are supposed to be used with. In the current labeling, the name of the test strips model (BMB-BA006A) was not included. The Advocate Redi-Code+ BMB-BA006A blood glucose test strips should only be used with the Advocate Redi-Code+ blood glucose meters with the model numbers BMB-EA001S and BMB-EA001A and manufactured by BroadMaster Bio-Tech Corp. The labeling error may lead users to believe they can use the Advocate Redi-Code+ BMB-BA006A blood glucose test strips with the Advocate Redi-Code blood glucose meters with model numbers TD-3223E, TD-4223E, TD-4223F, and TD-4276, which are manufactured by Taidoc Technology Corp. If the Advocate Redi-Code+ blood glucose test strips are used with the Taidoc meters listed here, the results could be inaccurate. People with diabetes carefully monitor their blood glucose levels and require urgent treatment for low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). False results could lead to inappropriate or delayed treatment that could harm a patient. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm400559.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
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Date Published Title Drug Source
2014-05-21 FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ Hydrocortisone with Pramoxine FDA
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Tolazamide Manufacturer
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Manufacturer
2014-06-24 FDA Adds Blood Clot Warning to Testosterone Products Methyltestosterone FDA
2014-06-26 FDA Warns: Docetaxel May Cause Alcohol Intoxication Docetaxel FDA
2014-06-30 FDA Warns That Over-the-Counter Topical Acne Medicines May Cause Serious Allergic Reactions Benzoyl Peroxide FDA
2014-07-03 Oral Lidocaine for Teething Pain May Cause Harm Lidocaine FDA
2014-11-14 FDA Raises Concern About Generic Extended-Release Methylphenidate Hydrochloride Tablets (generic Concerta) made by Mallinckrodt and Kudco Methylphenidate FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-25 Empty Gabapentin 300 mg Capsules From Aurobindo Pharma Prompt Recall Gabapentin FDA
2014-11-26 FDA Warns About Case of Progressive Multifocal Leukoencephalopathy (PML) With MS Drug Tecfidera (Dimethyl Fumarate) Dimethyl Fumarate FDA
2014-12-11 FDA Warns Ziprasidone (Geodon) May Cause Rare but Serious Skin Reactions Ziprasidone FDA
2015-03-05 FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Possible Increased Risk of Heart Attack and Stroke Methyltestosterone FDA
2015-05-27 FDA Warns About Possible New Side Effect of SGLT2 Inhibitors Canagliflozin / Metformin FDA
2015-08-25 Allergan Issues Voluntary Recall of Select Lots Of REFRESH Lacri-Lube, REFRESH P.M., FML, and Blephamide Over Safety Concerns Fluorometholone FDA
2015-08-28 FDA Warns About Possible Side Effect of DPP-4 Inhibitors Sitagliptin FDA
2015-11-12 FDA Completes Review of Blood-Thinning Medicine Plavix (Clopidogrel) Clopidogrel FDA
2016-02-03 Los Profesionales Sanitarios Informados: Viekirax (Ombitasvir, Paritaprevir, Ritonavir) No Recomendado En Pacientes Con Determinados Problemas En El Hígado AEMPS
2016-05-02 FDA Is Reviewing a Study Linking Fluconazole Use and Risk of Miscarriage Fluconazole FDA