5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer
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06/09/2011
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Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack
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03/01/2011
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Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials
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01/01/2011
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Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication
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01/13/2011
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Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
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06/03/2011
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Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
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01/03/2011
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American Regent Injectable Products: Recall - Visible Particulates in Products
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02/23/2012
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Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed
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06/02/2011
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Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns
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02/22/2011
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Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events
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11/04/2011
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Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia
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04/07/2011
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Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots
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10/27/2011
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Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled
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06/27/2011
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CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
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01/12/2012
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Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
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08/24/2011
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Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events
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07/22/2011
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Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling
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03/28/2011
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Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency
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05/03/2011
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Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
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08/03/2011
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Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets
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06/27/2011
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Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations
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06/24/2011
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Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose
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05/14/2012
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H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
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09/25/2012
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H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
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02/08/2012
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Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling
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02/07/2011
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Indomethacin for Injection: Recall of One Lot - Particulate Matter
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06/15/2011
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Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant
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03/28/2011
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Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies
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03/08/2011
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Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors
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12/22/2011
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Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes
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04/15/2011
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Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
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04/15/2011
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Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals
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03/30/2011
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Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
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10/21/2011
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Metronidazole Tablets, 250mg: Recall - Underweight Tablets
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01/06/2011
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Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose
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01/10/2011
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Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events
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12/19/2011
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Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury
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01/14/2011
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Nature Relief Instant Wart and Mole Remover: Recall - Risk of Severe Skin Burns
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06/27/2011
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Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems
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05/06/2011
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Nostrilla Nasal Decongestant: Recall - Bacterial Contamination
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10/21/2011
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Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS)
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07/07/2011
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Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation
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06/29/2012
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Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer
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07/21/2011
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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
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12/07/2011
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Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements
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03/30/2011
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Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use
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03/02/2011
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Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error
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09/16/2011
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Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment
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09/01/2011
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Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies
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05/07/2012
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Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor
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06/20/2011
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Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion
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06/13/2011
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Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions
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09/01/2011
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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn
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12/14/2011
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Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension
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10/11/2011
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Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
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07/11/2011
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Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor
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02/17/2011
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Topamax (topiramate): Recall - Musty Odor
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04/15/2011
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Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns
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03/04/2011
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Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination
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06/08/2011
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Trilipix (fenofibric acid): Drug Safety Communication - Label Change
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11/09/2011
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Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria
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09/07/2011
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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
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11/04/2011
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Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor
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06/29/2011
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Tysabri (natalizumab): Update of Healthcare Professional Information
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04/22/2011
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Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market
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03/02/2011
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Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage
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02/21/2011
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Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions
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04/06/2011
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Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)
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06/30/2011
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Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency
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08/04/2011
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Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis
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06/13/2011
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Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit
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10/25/2011
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Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations
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12/15/2011
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Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms
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09/15/2011
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Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
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10/21/2011
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