Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer
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06/15/2011
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Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning
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07/16/2010
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Alli 60 mg capsules (120 count refill kit): Counterfeit Product
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01/23/2010
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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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Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms
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12/17/2010
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Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
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07/13/2010
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Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall
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10/08/2010
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Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic
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05/28/2010
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Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events
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11/04/2011
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Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
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02/22/2010
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Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun
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12/16/2010
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Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors
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05/12/2010
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Benicar (olmesartan): Ongoing Safety Review
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04/14/2011
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Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update
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10/13/2010
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Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility
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04/07/2010
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Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning
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10/14/2010
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Coumadin 1 mg Tablet Blister Packs: Recall
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07/14/2010
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Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
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07/29/2010
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Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product
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12/24/2010
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Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials
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09/24/2010
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Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
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02/16/2010
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Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
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07/29/2010
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Exjade (deferasirox): Boxed Warning
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02/18/2010
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Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified
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11/05/2010
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Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis
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09/09/2010
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GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)
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10/20/2010
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GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer
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05/03/2010
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Heparin Sodium (B. Braun): Recall - Trace Contaminant
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10/29/2010
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Heparin: Change in Reference Standard
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04/07/2010
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Hospira Brand Liposyn and Propofol: Recall
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06/10/2010
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Hyland’s Teething Tablets: Recall - Risk of Harm to Children
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10/24/2010
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Hylenex recombinant (hyaluronidase human injection): Recall
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05/26/2010
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Intravenous Medications Manufactured by Claris: Recall due to contamination of products
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05/29/2010
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Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm
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10/21/2010
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Invirase (saquinavir): Ongoing safety review of clinical trial data
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02/23/2010
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Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis
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08/12/2010
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Lipitor (atorvastatin) 40 mg: Recall Specific Bottles
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12/23/2010
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Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
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04/15/2011
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Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
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02/17/2010
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McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall
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04/30/2010
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McNeil Consumer Healthcare Over-The-Counter Products: Recall
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07/08/2010
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Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events
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10/08/2010
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Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
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01/21/2010
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Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates
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10/29/2010
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Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility
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05/17/2010
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Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
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08/16/2010
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Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
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06/21/2010
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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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NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter
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08/02/2010
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Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms
|
08/02/2010
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Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
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03/11/2010
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Orlistat (marketed as Alli and Xenical): Labeling Change
|
05/26/2010
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PediaCare Children's Products [Blacksmith Brand]: Recall of four products
|
05/29/2010
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Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
|
03/12/2010
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Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
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05/12/2010
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Propoxyphene: Withdrawal - Risk of Cardiac Toxicity
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11/19/2010
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Propylthiouracil
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04/21/2010
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Proton Pump Inhibitors (PPI): Class Labeling Change
|
05/25/2010
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Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
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08/04/2010
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Rapamune (sirolimus): Drug Monitoring Recommendations
|
01/11/2010
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Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death
|
08/04/2011
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Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets
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12/13/2010
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Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in Products
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12/14/2010
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Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials
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12/29/2010
|
Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review
|
03/31/2010
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Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
|
08/20/2010
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Tamiflu: Counterfeit Product Sold on Internet
|
06/17/2010
|
Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children
|
12/14/2010
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Tygacil (tigecycline): Label Change - Increased Mortality Risk
|
09/01/2010
|
Tylenol 8 Hour Caplets 50 Count: Recall
|
10/19/2010
|
Tysabri (natalizumab): Update of Healthcare Professional Information
|
04/22/2011
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Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change
|
05/25/2010
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Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients
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09/15/2010
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Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
|
01/26/2010
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Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
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01/29/2010
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Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients
|
05/04/2010
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Zocor (simvastatin): increased risk of muscle injury with high doses
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03/19/2010
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Zyprexa (olanzapine): Use in Adolescents
|
01/29/2010
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