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Latest drug alerts and warnings.

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Title Date
Abacavir (Ziagen) and Abacavir-Containing Medications - Patient Screening Recommended 07/29/2008
Abacavir and Didanosine and Risk of Heart Attack - Ongoing Safety Review 03/28/2008
Abacavir Sulfate (Ziagen) and Lamivudine/Zidovudine (Combivir) - Third Party Tampering 4/12/2007
Abbott Blood Glucose Meter Display Problems 9/13/2007
Able Laboratories Inc. - Recalls All Products/Suspends Manufacturing 5/25/2005
ACCU-CHEC glucose meter device recall 1/23/2006
ACCU-CHEK Softclix Lancet Recall 06/03/2009
Accusure Insulin Syringe Recall - updated 10/28/2009
Accutane (Isotretinoin) - New Informational FDA web site 3/29/2007
Accutane and Generic Isotretinoin - iPLEDGE Risk Management Program Modification 10/12/2006
Accutane and Generic Isotretinoin: New risk management program - iPLEDGE 8/17/2005
Acetaminophen (Tylenol®) Pediatric Liquid Products Recalled Due to Possible Bacterial Contamination - UPDATED 10/01/2009
Acetaminophen Concentrated Drops – Brookstone Pharmaceuticals Voluntary Recall Due to Packaging Concerns 07/16/2009
Acetaminophen – FDA Actions to Prevent Overdose 07/01/2009
Acetaminophen 500 mg Tablets (Store Brands) - Recall 11/10/2006
Actavis Drug Recall 08/05/2008
Actavis Totowa Digoxin (Digitek®) Recall 04/29/2008
Actiq lozenges 9/3/2003
Adacel (DTaP) and Daptacel (Tdap) Administration Errors 2/2/2007
Adalimumab (Humira) and infections/hypersensitivity/and hematologic reaction 11/9/2004
Advanced Medical Optics Recall - Healon D Ophthalmic Viscosurgical Device 12/12/2008
Advanced Medical Optics Contact Lens Solution Recall 5/30/2007
Alaris System Class I Recall 08/07/2009
Albumin considered safe for use in critically ill patients 5/20/2005
Alcohol-Free Mouthwash - Recall 05/08/2008
Alefacept (Amevive) not recommended for HIV patients 11/15/2005
Alemtuzumab (Campath) Associated with Severe Idiopathic Thrombocytopenic Purpura in Multiple Sclerosis Trials 12/2/2005
Alglucosidase Alfa (Myozyme) - Formation of Black Particles During Reconstitution 4/12/2007
Altocor® (lovastatin extended release) withdrawal/replaced by Altoprev® 8/11/2004
Amantadine and Rimantadine/High Levels of Resistance By Influenza A H3N2 Viruses 1/19/2006
Amicar (aminocaproic acid) and Omacor (omega-3-acid ethyl esters) Dispensing Errors 3/2/2006
Amiodarone hydrochloride tablets (Cordarone®/generic) - Patient Medication Guide Requirement 1/13/2005
Ammonul (sodium phenylacetate and sodium benzoate) Injection - Filter Required 09/25/2008
Amphetamine/Dextroamphetamine (Adderall/Adderall XR)associated with sudden death/sales suspended on Canadian market 2/10/2005
Anagrelide (Agrylin) exposure increased in patients with hepatic impairment/contraindicated in severe hepatic impairment 2/10/2005
Anesthetic Agents for Cosmetic Procedures/Topical - Potentially Fatal Adverse Effects 2/12/2007
Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors) Associated with Birth Defects in First Trimester 6/9/2006
Antidepressants and Suicidality in Young Adults 5/7/2007
Antidepressants and Suicidality in Adults to be Evaluated 7/1/2005
Antidepressant labeling changes 7/6/2004
Antidepressants and suicidality in children: FDA requests labeling change 10/15/2004
Antiepileptic Drugs and Increased Risk of Suicidal Behavior or Suicidal Ideation 05/06/2009
Antipsychotics (Conventional and Atypical) - Increased Risk of Death in Elderly Patients Taking Antipsychotics for Dementia-Related Psychosis 06/16/2008
Anti-Tumor Necrosis Factor (TNF) Agents (adalimumab [Humira], certolizumab pegol [Cimzia], etanercept [Enbrel], infliximab [Remicade], golimumab [Simponi]) —Ongoing Safety Review of Malignancy Risk - UPDATE 09/02/2009
Aprotinin (Trasylol) Marketing Temporarily Suspended Pending Ongoing Safety Review - Update 11/5/2007
Aprotinin (Trasylol): Increased Risk Of Myocardial Infarction/Stroke/Renal Dysfunction/and Anaphylaxis - Update 12/18/2006
Aranesp (darbepoetin alfa) and Adverse Effects with Off-Label Dosing 1/14/2005
Arava (leflunomide) 11/21/2003
Aspirin and Ibuprofen Drug Interaction 9/14/2006
Astellas Recall of Lots of Several Medications Due to Stolen Transport Trailer 07/23/2009
Atomoxetine (Strattera) - Increased Risk of Suicidal Ideation in Pediatric Patients 10/2/2005
Atomoxetine (Strattera) associated with liver toxicity 12/22/2004
Atypical Antipsychotics - increased mortality in elderly patients with dementia 4/12/2005
Atypical antipsychotics and hyperglycemia 9/1/2004
Avian Flu Therapies/Fraudulent 1/3/2006
Avastin (Bevacizumab) and Tracheoesophageal Fistula 4/24/2007
Avastin (bevacizumab) increased risk of arterial thromboembolic events - Update 1/5/2005
Baby's Bliss Gripe Water by MOM Enterprises Recalled 9/28/2007
Balanced Salt Solution by Cytosol Labs Recalled 2/15/2006
Becaplermin Gel (Regranex) and Risk of Cancer Death - Ongoing Safety Review 06/10/2008
Benzocaine Sprays - Increased Risk of Methemoglobinemia 2/15/2006
Benzoyl Peroxide 10% Topical Acne Gel - Product Recall 11/18/2008
Bevacizumab (Avastin®) and sunitinib (Sutent®) – combined use may increase risk of microangiopathic hemolytic anemia 07/14/2008
Bevacizumab (Avastin) and Tracheoesophageal Fistula 4/24/2007
Bevacizumab (Avastin®) and Risk of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) and Nasal Septum Perforation 9/27/2006
Bioidentical Hormone Replacement Therapy - Misleading Information 01/11/2008
Bismacine Injection (Chromacine) - Avoid Use for Lyme Disease 7/25/2006
Bisphosphonates - Update of Safety Review of FDA Early Communication Regarding Atrial Fibrillation 11/13/2008
Bisphosphonates (alendronate [Fosamax, Fosamax plus D], etidronate [Didronel], ibandronate [Boniva], pamidronate [Aredia], risedronate [Actonel, Actonel and calcium], tiludronate [Skelid], zoledronic acid [Reclast, Zometa]) – Bone, Joint, and Musculoskeletal Pain Reminder 01/07/2008
Bisphosphonate-Induced Renal Dysfunction in Oncology Practice 3/10/2005
Body Building Products Containing Unapproved Synthetic Steroids – FDA Issues Warning 11/18/2009
Bosentan (Tracleer) 5/Cause Hepatotoxicity 3/3/2006
Botulinum Toxin Types A (Botox, Botox Cosmetic, Dysport) and Botulinum Toxin Type B (Myobloc) – Safety Review Update and Names Changed to OnabotulinumtoxinA (Botox, Botox Cosmetic), AbobotulinumtoxinA (Dysport), and RimabotulinumtoxinB (Myobloc) 08/04/2009
Brazilian Diet Pills 5/Contain Chlordiazepoxide/Fluoxetine/or Stimulants 1/19/2006
Bupropion (Zyban and generics) – Neuropsychiatric Events and Suicidality Warnings added to the Prescribing Information - Update 07/06/2009
Caffeine Citrate Powder/Purified - Recall 5/22/2007
Calcilo XD Infant Formula - Product Recall 06/04/2008
Caraco Medications Seized by US Marshals Due to Ongoing Quality Problems UPDATED 06/30/2009
Carbamazepine (Tegretol) - Skin Reactions More Common in Patients with Human Leukocyte Antigen B*1502 Allele 12/12/2007
Cefepime (Maxipime) - Ongoing Safety Review 06/18/2009
Ceftriaxone Injection (Rocephin) - Interaction with Calcium Products and New Contraindication in Hyperbilirubinemic Neonates — UPDATE 04/14/2009
Celecoxib (Celebrex) cardiovascular risk 12/21/2004
cetirizine HCl/Name confusion with 2/10/2005
Cetuximab (Erbitux) - Additional Monitoring for Electrolyte Abnormalities and Infusion Reactions 9/15/2005
Changes to CII prescribing - Postdating no longer allowed 3/23/2005
Children's Tylenol Meltaways 80 mg/Children's Tylenol SoftChews 80 mg/and Junior Tylenol Meltaways 160 mg - recalled due to confusing packaging and labeling 6/6/2005
Chiron's Influenza Virus Vaccine (Fluvirin) Delayed/Shipment of 9/2/2004
Chondrolysis Associated with Continuously Infused Local Anesthetics [bupivacaine (Marcaine; Sensorcaine); chloroprocaine (Nesacaine); lidocaine (Xylocaine); mepivacaine (Carbocaine; Polocaine); procaine (Novocain); ropivacaine (Naropin)] 11/17/2009
Clarcon Hand Sanitizers and Skin Protectants Recall 06/11/2009
Clarithromycin (Biaxin/Biaxin XL)- study shows increased cardiovascular mortality 12/13/2005
Clopidogrel Bisulfate (Plavix) – Potential Interactions with Omeprazole (Prilosec) and Esomeprazole (Nexium) – Ongoing Safety Review – UPDATE 11/17/2009
Chlorhexidine Gluconate Skin Preparation Cloth - Recall 07/02/2008
Clozapine Labeling Changes - White Blood Cell Count Monitoring Changes 1/13/2006
Cochlear Implant Device Increases Risk of Pneumococcal Meningitis – Immunization Recommended 10/17/2007
Codeine use in Nursing Mothers with a Specific CYP2D6 Genotype may lead to Morphine Overdose in the Nursing Infant 8/17/2007
Colchicine Products, FDA Bans the Manufacture of Unapproved Injectable 02/06/2008
Colchicine Injection - Recall of Compounded Product 5/3/2007
Colistimethate (Coly-Mycin M®, generics) Inhalation Possibly Associated With Death 7/2/2007
Combivir (Lamivudine/Zidovudine) and Ziagen (Abacavir Sulfate) - Third Party Tampering 4/12/2007
Compounded Inhalation Solutions 5/Not Be Safe, Unapproved 8/11/2006
Compounding Topical Anesthetic Creams and Other Products/FDA Warns Pharmacies Against 09/25/2009
Contact Lens Solutions: Fungal Eye Infections in Soft Contact Lens Wearers 4/14/2006
Corvalol - Unapproved Drug Contains Phenobarbital 11/21/2008
Cough and Cold Medications Update - Infant Deaths and Use in Children — UPDATED 10/10/2008
Counterfeit Medications on the Internet – FDA Warning about Orlistat (Xenical) 5/3/2007
COX-2 Selective Inhibitors and NSAIDs - Patient Medication Guide Requirement 6/16/2005
Creon – Newly Approved Formulation Requires New Prescription 07/06/2009
Cyclopentolate and Tropicamide Administration Errors 06/27/2008
Daptacel (DTaP) and Adacel (Tdap) Administration Errors 2/2/2007
Daptomycin (Cubicin) – MBT Contaminant When Stored in ReadyMED Elastomeric Pump 04/10/2008
Darbepoetin alfa [Aranesp]/Erythropoiesis-Stimulating Agent Increases Death in Non-Chemotherapy-Induced Anemia 2/20/2007
Darbepoetin alfa/Epoetin alfa: Hemoglobin Target above 12 g/dL Increases Cardiovascular Risk 11/20/2006
Darunavir (Prezista)- Hepatotoxicity Warnings 3/14/2008
Daytrana™ (Methylphenidate Transdermal System) Recall 9/7/2007
DEA Numbers 5/Begin With Letter "F" 10/16/2006
Deferasirox (Exjade): Early Communication about an Ongoing Safety Review 09/28/2009
Deferasirox (Exjade) - Potentially Fatal Renal, Hepatic, Hematologic, and Allergic Events 5/23/2007
Denileukin diftitox (Ontak) 5/Cause Visual Loss 3/17/2006
Desmopressin - Risk of Hyponatremia and Seizures 12/06/2007
Dextroamphetamine/Amphetamine 20 mg Tablet Recall by Barr 08/18/2009
Dextroamphetamine sulfate 5 mg tablets by Ethex recall 10/17/2008
Dextroamphetamine (Dexedrine/Dexedrine Spansule) Labeling Changes/Including Sudden Death 2/23/2007
Dextromethorphan abuse associated with death 5/25/2005
Diazepam Rectal Gel (Diastat Acudial): Applicator Defect 5/Prevent Delivery of Complete Dose. 3/31/2006
Digoxin Tablet Recall by Caraco - UPDATED 05/13/2009
Disposal of Prescription Medications in the Community - New Federal Guidelines - UPDATED 10/19/2009
Dolasetron (Anzemet) 2/3/2003
droperidol (Inapsine) 1//2002
Drotrecogin alfa [activated] (Xigris) – Ongoing Safety Review 02/05/2009
Drotrecogin alfa (Xigris) Not Effective in Pediatric Patients with Severe Sepsis 04/29/2005
Drug Storage Changes - Date All Multidose Vials 3/2/2005
Dulcolax Products - not all formulations contain bisacodyl 4/27/2004
Duloxetine (Cymbalta®) 5/Exacerbate Hepatic Injury in Patients with Preexisting Liver Disease 10/18/2005
Duragesic Patch Recall UPDATE 4/6/2004
Duragesic Patch Recall 2/23/2004
Edetate Disodium - Sound-Alike Confusion with Edetate Calcium Disodium 01/22/2008
Efalizumab (Raptiva®) withdrawal 04/13/2009
Efalizumab (Raptiva) and Progressive Multifocal Leukoencephalopathy (Update) 02/20/2009
Efalizumab (Raptiva) associated with hemolytic anemia/thrombocytopenia/and serious infection 7/20/2005
Efavirenz (Sustiva) - Pregnancy Risk has Changed to Category D (positive evidence of fetal risk). 6/13/2005
Electronic Cigarette – A Potential Health Hazard 07/28/2009
Enoxaparin (Lovenox) adjust dose for severe renal impairment 8/17/2004
Entecavir (Baraclude) and Possible HIV Resistance — UPDATED 8/20/2007
Ephedra 12/30/2003
Ephedrine alkaloids in dietary supplements illegal to market in US 9/7/2006
Epoetin alfa (Eprex) in the Treatment of Acute Ischemic Stroke 09/30/2008
Epoetin alfa/Darbepoetin alfa: Hemoglobin Target above 12 g/dL Increases Cardiovascular Risk 11/20/2006
Epoetin Alfa (Epogen®/Procrit®) and Darbepoetin Alfa (Aranesph®) - Associated with Pure Red Cell Aplasia 12/2/2005
Erectile Dysfunction Dietary Supplements - Dangerous Ingredients — UPDATED 11/18/2009
Erectile Dysfunction Drugs and Vision Loss 7/12/2005
Ergotamine – FDA Halts Marketing of Unapproved Products 3/5/2007
Erlotinib (Tarceva) and New Safety Information 05/11/2009
Erlotinib (Tarceva) and Hepatic Dysfunction 09/24/2008
Ertapenem Sodium (Invanz) Recall 7/9/2007
Etravirine (Intelence™): Severe Skin and Hypersensitivity Reactions 09/03/2009
Erythropoiesis-Stimulating Agents (Darbepoetin alfa [Aranesp], Erythropoietin alfa [Epogen, Procrit]) – Proposed Changes in Product Labeling 08/07/2009
Erythropoiesis-Stimulating Agents (Darbepoetin alfa [Aranesp], Epoetin alfa [Epogen, Procrit]) - Revised Black Box Warnings - UPDATED 03/14/2008
Etanercept (Enbrel) Black Box Warning of Infection Risk— UPDATED 05/02/2008
Ethex Recalls Additional Products More Than 60 Drug Products—Updated 02/10/2009
Exenatide (Byetta®) – Altered Kidney Function Reported 11/03/2009
Exenatide (Byetta) and Pancreatitis— UPDATED 08/20/2008
Ezetimibe/Simvastatin versus Simvastatin Alone (ENHANCE) – Update of Ongoing Data Review 01/12/2009
Famotidine and Lorazepam Administration Errors 9/7/2006
Fentanyl Boxed Warnings 7/12/2005
Fentanyl Buccal Tablet (Fentora®) - Inappropriate Use Causes Death/Adverse Effects— UPDATED 9/28/2007
Fentanyl Transdermal System Recall (Actavis, Abrika) 03/04/2008
Fentanyl 50 mcg/hour Transdermal System Recall (Duragesic - Janssen, generic - Sandoz) 01/02/2009
Fentanyl 25 mcg/hour Transdermal System Recall (Duragesic - Janssen, generic - Sandoz) 02/19/2008
Fentanyl Transdermal Patch (Duragesic, generics) - Cautions About Safe and Appropriate Use 12/24/2007
Floranex (Lactobacillus) and Florinef (fludrocortisone) Name Confusion 1/2/2007
Flu Vaccine Update - Keep Vaccinating 02/20/2009
Fluoroquinolones and Tendinitis and Tendon Rupture 07/09/2008
Formoterol Fumarate (Foradil) and Tiotropium Bromide (Spiriva) Capsules, Correct Use of 03/04/2008
Formula (Infant) with Iron Recall - Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature 5/30/2007
Fortovase/Invirase (Saquinavir) plus Ritonavir (ritonavir boosted saquinavir) interacts with rifampin - increased liver toxicity reported 2/10/2005
Gabapentin 100 mg capsules (Neurontin) - Recall 3/22/2005
Gadolinium-Containing Contrast Agents (Omniscan®/OptiMARK®/Magnevist®/ProHance®/MultiHance®) Possible Association With Serious Nephrogenic Fibroses — UPDATE 9/28/2007
Galactose, Maltose, and Xylose Products May Falsely Elevate Glucose Results – Update 08/14/2009
Galantamine brand name changed to Razadyne 4/25/2005
Galantamine (Reminyl) - possible increased mortality in patients with mild cognitive impairment 4/5/2005
Gatifloxacin (Tequin) and Blood Glucose Abnormalities/Contraindicated in Diabetics 2/17/2006
Gefitinib (Iressa) - shows no survival benefit for non-small cell lung cancer/use discouraged. 6/17/2005
GenTeal Gel and GenTeal GelDrops Artificial Tears Recall (Novartis Ophthalmics) 11/23/2005
Gentlease Infant Formula Recalled 2/24/2006
Genzyme Products including alglucosidase alfa (Myozyme), algasidase beta (Fabrazyme), imiglucerase (Cerezyme), laronidase (Aldurazyme), and thyrotropin alfa (Thyrogen) – Possible Particulate Matter Contamination 11/16/2009
Goldline Brand Extra-Strength Acetaminophen 500 mg (Genapap/Genebs)/Recall of 5/5/2006
Granisetron (Kytril) 2/3/2003
Griseofulvin (Grifulvin V) Oral Suspension - Recall 4/12/2007
Guillain Barre Syndrome associated with meningococcal conjugate vaccine 10/4/2005
Haloperidol - Updated Labeling Regarding Risk of Torsades de Pointes and QT Prolongation 9/19/2007
Heparin: Change in Reference Standard- New Universal Standardization in Heparin Potency 10/05/2009
Heparin Administration Errors - Use of Incorrect Concentrations 2/12/2007
Heparin Lock Flush Pre-filled Syringes and Normal Saline Pre-filled Flush Syringes Recalled by AM2 PAT, Inc. - Update 01/23/2008
Heparin -Induced Thrombocytopenia - Delayed-Onset Warning 12/12/2006
Heparin - Voluntary Recall of All Baxter Heparin Vials, B. Braun Heparin Large Volume Infusion Bags, and Covidien (Kendall) Heparin Flush Prefilled Syringes - Update 06/18/2008
Hepatitis B Vaccine Products Stocked in the Pharmacy 9/6/2005
HMG-CoA-reductase inhibitors do not increase incidence of amyotrophic lateral sclerosis (AML) 09/30/2008
hormone replacement therapy update 4/16/2004
Hospira Recall - Potassium 20 mEq in 5% Dextrose/ 0.45% Sodium Chloride 12/09/2008
Human Papillomavirus Recombinant Quadrivalent Vaccine, Types 6, 11, 16, 18 (Gardasil®) -Safety Update 07/25/2008
Human rabies vaccine (Imovax - Aventis Pasteur) 4/6/2004
Hydralazine HCl 20mg/mL Injection - Recall 8/18/2006
Hydrocodone Long-Acting Antitussives (Tussionex) - Safe Use 04/24/2008
Hydrocodone Antitussives - FDA Halts Marketing of Unapproved Products 9/28/2007
Hydromorphone 2 mg Tablet Recall by Ethex 12/24/2008
Hydromorphone Extended Release (Palladone) withdrawn for safety reasons 7/14/2005
Hydroxyurea Associated Cutaneous Vasculitic Toxicities 1/26/2006
Hyperactivity Medications: Patient Medication Guide Required due to Cardiovascular and Psychiatric Adverse Effects 2/23/2007
Ibritumomab tiuxetan (Zevalin) and Rituximab (Rituxan) - Potentially-fatal Skin and Mucus Membrane Reactions 11/3/2005
Ibuprofen and Aspirin Drug Interaction 9/14/2006
Ibuprofen topical OTC formulations marketed unlawfully – Warning letters issued by the FDA 08/26/2009
Icy Hot Heat Therapy Products - Recall 02/12/2008
Imatinib Mesylate (Gleevec®) - Cardiac Events 10/19/2006
Immune Globulin (GamaSTAN S/D™) - Uncalibrated Syringes 03/06/2008
Immunosuppressant Drugs – Labeling Changes Warning of Increased Risk of Opportunistic Infections 07/15/2009
Infants' Mylicon Gas Relief Dye Free Drops Recall 11/13/2008
Inhaled Insulin (Exubera) and Lung Cancer 04/10/2008
Insulin Pens and Cartridges – Risk of Blood-Borne Disease Transmission with Shared Use 03/20/2009
Insulin Syringe (ReliOn) Recall 11/07/2008
Interferon Gamma-1b (Actimmune) - Early Termination of Trial for Idiopathic Pulmonary Fibrosis 3/9/2007
(IGIV) Intravenous Immune Globulin 5/20/2002
Infant Formula by Gentlease Recalled 2/24/2006
Infliximab (Remicade) associated with hepatotoxicity 12/22/2004
Infliximab (Remicade) new hematologic side effects warnings 8/25/2004
Insulin Detemir (Levemir) – Stolen Vials Resurface, Product Potentially Defective 08/26/2009
Insulin Glargine (Lantus) – Risk of Cancer 07/01/2009
Insulin Products/Eli Lilly Discontinuing Humulin U Ultralente/Humulin L Lente/Regular Iletin II/and NPH Iletin II 7/7/2005
Interferon Alfa-2b (Intron A) Injection Pens – Recall of Several Lots by Schering-Plough 11/11/2009
Interferon beta-1b (Betaseron) 5/cause hepatotoxicity 4/25/2005
Interferon beta-1a (Avonex) - Reports of serious hepatic injury 3/17/2005
Iopromide 370 mg/mL Injection (Ultravist) Recall 7/25/2006
Iron dextran injection (Dexferrum) – Black Box Warning for Potentially Fatal Anaphylactic Reaction 10/20/2009
Isotretinoin (Accutane, generic) – New Informational FDA web site 3/29/2007
Kaopectate - Reformulation 8/2 /2005
Ketamine HCl (Ketalar) 10mg/mL Injection – Recall 12/14/2006
Ketorolac Tromethamine Injection – Voluntary Recall 10/22/2009
KV Pharmaceutical Tablet Shipment Suspension 12/24/2008
Lamictal (Lamotrigine) and Lamisil (Terbinafine) Name Confusion 8/7/2006
Lamisil (Terbinafine) and Lamictal (Lamotrigine) Name Confusion 8/7/2006
Lamivudine/Zidovudine (Combivir) and Abacavir Sulfate (Ziagen) - Third Party Tampering 4/12/2007
Lamivudine/Abacavir and Tenofovir7/31/2003
Lamotrigine (Lamictal) During Pregnancy 5/Increase Risk of Cleft Lip or Cleft Palate 10/3/2006
Lantus (insulin glargine [rDNA origin] injection recall Lot 40D024/Lot 40D025/Lot 40D027) 8/19/2004
Levoxyl (levothyroxine) 10/6/2004
Linezolid (Zyvox®) - Increased Mortality Following Treatment of Intravascular Catheter-Related Infections 3/19/2007
Liposyn II and Liposyn III (Hospira) – Recall of 85 Lots Due to Presence of Particulate Matter 11/11/2009
Live Oral Pentavalent Rotavirus Vaccine (RotaTeq) - Post-Marketing Reports of Intussusception 2/20/2007
Live Oral Pentavalent Rotavirus Vaccine (RotaTeq) – Reports of Kawasaki Disease 6/19/2007
Long-Acting Beta 2-Agonists Can Increase Severe Asthma Episodes11/18/2005
Lopinavir/Ritonavir Oral Solution (Kaletra) - Potential Risk of Overdose in Children 8/15/2007
Lorazepam and Famotidine Administration Errors 9/7/2006
Magnesium Sulfate and Potassium Phosphate – Potential for Error 08/06/2009
MBI Ordered to Cease Manufacturing and Distributing Products 12/2/2005
Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) - Ongoing Safety Review 03/04/2008
Medicaid Tamper-Resistant Requirement - Delayed 6 Months 9/28/2007
Medroxyprogesterone acetate injection (Depo-Provera® Contraceptive Injection) associated with bone mineral density loss 11/22/2004
medroxyprogesterone acetate & estradiol cypionate injectable suspension (Lunelle™) 10/14/2002
mefloquine (Lariam®) 10/04/2002
meningococcal conjugate vaccine/Guillain Barre Syndrome associated with 10/24/2006
meningococcal polysaccharide vaccine 12/15/2005
METABOSLIM Dietary Supplement Contains Undeclared Sibutramine 8/22/2007
Methadone Hydrochloride (Dolophine, generics) – Cardiac and Respiratory Deaths 11/28/2006
Methotrexate Injection From Bedford Recalled Due to Ethylene Glycol Content 10/28/2002
Methylphenidate Transdermal System (Daytrana™) Recall 9/7/2007
Methylphenidate hydrochloride 2.5 mg/5 mg/and 10 mg Chewable Tablets (Methylin CT) – Recall Update 2/10/2005
Metoclopramide (Reglan, generic) – Black Box Warning for Tardive Dyskinesia 02/27/2009
Micro-bubble Perflutren Contrast Agents (Definity and Optison) Associated with Deaths and Serious Cardiopulmonary Reactions - Update 07/17/2008
Midazolam Hydrochloride and Furosemide – Potential for Error 08/10/2009
Mifepristone (Mifeprex/RU-486) associated with serious infection and bleeding - UPDATE 3/20/2005
Minocycline (Solodyn) - Two lots recalled due to product mix-up 05/21/2008
Mislabeled Internet Medications – Dangerous Ingredients 2/21/2007
Mitoxantrone (Novantrone) - Cardiac Monitoring 07/30/2008
Mitoxantrone (Novantrone) - Cardiotoxicity and Secondary Acute Myelogenous Leukemia (AML) in Patients with Multiple Sclerosis 5/25/2005
Modafanil (Provigil) - Rash and Psychiatric Warnings 10/25/2007
Mommy's Bliss Nipple Cream - Harmful Ingredients for Nursing Babies 05/30/2008
Montelukast (Singulair) and Risk of Behavior Changes, Mood Changes, or Suicidality - Ongoing Safety Review 06/12/2009
Morphine Extended Release (Avinza) - Alcohol 5/cause dose-dumping 11/4/2005
Morphine sulfate oral solutions 10/10/2003
Motrin/Children's chewable 5/14/2004
Mycophenolate Mofetil (CellCept®) associated with Pure Red Cell Aplasia (PRCA) 08/17/2009
Mycophenolate products (Cellcept – mycophenolate mofetil, Myfortic – mycophenolic acid) – Medication Guide Now Required 03/24/2009
Mycophenolate Mofetil (Cellcept) and Mycophenolic Acid (Myfortic) and Birth Defect Risk 05/16/2008
Mycophenolate Mofetil (CellCept) and Mycophenolate Acid (Myfortic) and risk of Progressive Multifocal Leukoencephalopathy – Ongoing Safety Review 06/30/2008
Mycophenolate Products (Cellcept, Myfortic) – Pregnancy Risk Category Updated 11/27/2007
Mycophenolate Mofetil (Cellcept) Plus Sirolimus (Rapamune) – Increased Acute Rejection In Cardiac Transplant Patients 2/26/2007
Mycophenolic Acid (Myfortic®) – warning for risk of Pure Red Cell Aplasia (PRCA) 09/09/2009
Myozyme (Alglucosidase Alfa) - Formation of Black Particles During Reconstitution 4/12/2007
Nalbuphine (Nubain) - Use During Labor and Delivery 1/10/2006
Naltrexone Extended-Release Injectable Suspension (Vivitrol) – Injection Site Reactions 08/13/2008
Naproxen (Aleve/Anaprox/Naprelan/Naprosyn) cardiovascular risk 12/21/2004
Natalizumab (Tysabri) Monotherapy and Progressive Multifocal Leukoencephalopathy 09/22/2008
Natalizumab (Tysabri) - Reports of Liver Injury after Natalizumab Use 02/29/2008
Natalizumab (Tysabri) - Resumed Marketing With a Special Restricted Distribution Program 3/1/2005
National Provider Identifier (NPI) - Personal Information Alert — UPDATED 8/27/2007
NC Solution, and other Products by General Therapeutics Corp. Seized 11/2/2007
Nefazodone 50 mg/100 mg/150 mg/200 mg/and 250 mg Tablets Recall (Ivax Pharmaceuticals) 3/31/2005
Nelfinavir Mesylate (Viracept) - New Impurity Specifications 9/14/2007
Nesiritide appropriate use/new guidelines for 7/20/2005
Nesiritide 5/adversely effect short-term survival and kidney function in patients with decompensated heart failure 5/20/2005
Neuraminidase Inhibitors, Oseltamivir Phosphate (Tamiflu) and Zanamivir (Relenza), Associated with Neuropsychiatric Events 04/03/2008
Nevirapine (Viramune®) - Risk factors for liver toxicity 1/20/2005
Nifedipine (Nifediac™ CC) Extended Release Tablets- Recall 07/09/2008
Nimodipine boxed warning: Do not give parenterally 2/1/2006
NSAIDs and COX-2 Selective Inhibitors - Patient Medication Guide Requirement 6/16/2005
Non-Acetone Nail Polish Remover (Personal Care Products) – Recall, Potential for Chemical Burns) 4/29/2009
Norelgestromin/ethinyl estradiol patch (Ortho Evra) May Increase Blood Clot Risk 9/21/2006
norethindrone and ethinyl estradiol tablets (Nortrel) 7//2003
Normal Saline Flush Recall (B. Braun) 9/19/2007
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection/[rDNA origin]) NovoLog (insulin aspart [rDNA origin] injection) - Change in Packaging to Help Prevent Dispensing Errors 9/16/2005
NuCel Labs “Eye Drops” and “Eye/Ear Wash” Recalled 02/01/2008
olanzapine/Name confusion with 2/10/2005
Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza 8/16/2007
Omacor (omega-3-acid ethyl esters) and Amicar (aminocaproic acid) Dispensing Errors 3/2/2006
Omalizumab (Xolair®) – Ongoing Safety Review Update 07/16/2009
Omalizumab (Xolair) - Reports of Delayed Anaphylaxis 7/3/2007
Omeprazole (Prilosec/Zegerid/generic) and Esomeprazole (Nexium) - Possible Association with Cardiac Events 12/12/2007
OneTouch® Blood Glucose Test Strips - Counterfeit Alert 10/17/2006
OneTouch® Test Strips 1/30/2003
Ondansetron (Zofran) 2/3/2003
Oral Colchicine (Colcrys) – Severe Drug Interactions with Strong CYP3A4 and P-glycoprotein Inhibitors 08/03/2009
Orlaam® (levomethadyl hydrochloride acetate) 9/10/2003
Orlistat (Xenical and Alli): Ongoing Safety Review 08/28/2009
Orlistat (Xenical) - FDA Warning about Counterfeit Medications on the Internet 5/3/2007
Ortho Evra® (norelgestromin/ethinyl estradiol) Labeling Update 01/23/2008
Ortho Evra: higher estrogen exposure than oral contraceptives 11/15/2005
Oseltamivir (Tamiflu) Oral Suspension—Potential for Dosing Errors 09/29/2009
Oxcarbazepine (Trileptal) 5/cause serious skin and multiorgan hypersensitivity reactions 4/25/2005
Oxycodone Extended-Release Tablets From Endo, Dava, and Watson - Discontinued 7/5/2007
OxyContin (oxycodone extended-release) manufacturer pleads guilty to misbranding and misrepresenting product 5/11/2007
Pai You Guo Dietary Supplement Contains Undeclared Sibutramine and Phenolphthalein 11/13/2009
Pamidronate and Zoledronic acid - reports of jaw osteonecrosis 5/20/2005
Pantoprazole (Protonix) I.V. glass vial breakage 9/27/2004
Paroxetine (Paxil®/Paxil CR®) Labeling Changes - Suicidality in Adults 10/08/2009
Patient Medication Guide Requirement - NSAIDs and COX-2 Selective Inhibitors 6/16/2005
Paxil and Paxil CR - updated Pregnancy Precautions 12/8/2005
Pediatric Injectable Drugs, 8th Edition (The Teddy Bear Book), Correction Notice – Typographical Errors in 08/17/2009
Pegaptanib Sodium Injection (Macugen): Labeling Changes Due to Reports of Anaphylaxis and Angioedema 4/7/2006
Pemoline Products Withdrawn from Market due to Risk of Liver Toxicity 10/28/2005
Penicillin G benzathine/Penicillin G procaine (Bicillin C-R) and Penicilln G benzathine (Bicillin L-A) - Inappropriate Use for Syphilis 12/1/2004
Peramivir Injection – Emergency Use Authorization for H1N1 Influenza 10/26/2009
pergolide mesylate (Permax) 2/25/2003
Pergolide Products Withdrawn From Market Due to Heart Valve Damage 3/30/2007
Perrigo Infant Drops containing Acetaminophen/Dextromethorphan/or Pseudoephedrine - Recall of 8/4/2005
PharmaFab to Stop Manufacturing Unapproved Drugs 4/27/2007
Phenytoin and Fosphenytoin - Skin Reactions More Common in Patients with the Human Leukocyte Antigen Allele, HLA*B 1502. 11/25/2008
Phosphocol P 32 - Increased Risk of Leukemia and Radiation Injury 09/18/2008
Pioglitazone (Actos) and Rosiglitazone (Avandia) - Stronger Warnings about Heart Failure 8/15/2007
Pioglitazone (Actos/Actoplus Met/Duetact) and Rosiglitazone (Avandia/Avandamet/Avandaryl) Increased Fracture Risk - Update 3/9/2007
Pimecrolimus (Elidel) and Tacrolimus (Protopic)/Potential Cancer Risk With Topical 1/24/2006
Premarin/Prempro/and Premphase 2/16/2006
Prevnar (Pneumococcal 7-valent Conjugate) Vaccine Recall 7/20/2009
Promethazine Hydrochloride Injection – Black Box Warning for Severe Tissue Injury 09/17/2009
Promethazine (Phenergan) injection classified as vesicant 4/25/2005
Promethazine and Fatal Respiratory Depression In Children Under Age 2 - Use Contraindicated 2/18/2005
Propafenone HCL 225 mg tablet recall by Watson 03/25/2009
Propofol (Hospira) – Recall of 73 Lots Due to Presence of Particulate Matter 11/11/2009
Propofol (Teva) – Recall of Two Lots Due to Presence of Endotoxin - UPDATE 07/17/2009
Propofol (Diprivan/generics) - Adverse Events Resembling Bacterial Sepsis 6/19/2007
Propoxyphene – Labeling Changes to Prevent Overdose 07/09/2009
Propylthiouracil (PTU) – Risk of Hepatotoxicity 06/04/2009
Quinine Sulfate - FDA Orders Halt of the Sale of Unapproved Products 12/13/2006
Rabies Immune Globulin (HyperRAB S/D) - Uncalibrated Syringes 02/25/2008
Ranibizumab (Lucentis®) 0.5 mg Increases Stroke Risk - UPDATED 2/1/2007
Razadyne - brand name changed from Galantamine 4/25/2005
Recombinant Factor VIIa (NovoSeven) - Increased Risk of Arterial Thromboembolic Events 12/2/2005
Red Yeast Rice Supplements 5/Contain Lovastatin 8/15/2007
Remifentanil Hydrochloride (Ultiva) – Typographical Error in the Handbook on Injectable Drugs 11/06/2009
Rho(D) Immune Globulin Intravenous (WinRho) - Hematologic Safety Reports 1/12/2006
Rimantadine and Amantadine/High Levels of Resistance By Influenza A H3N2 Viruses 1/19/2006
risperidone (Risperdal® - Janssen Pharmaceutical/Inc.) 4//2003
Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy (PML) 10/26/2009
Rituximab (Rituxan) and Ibritumomab tiuxetan (Zevalin) - Potentially-fatal Skin and Mucus Membrane Reactions 11/3/2005
Rituximab and Hepatitis 10/11/2004
Rofecoxib (Vioxx®) withdrawn due to cardiovascular risk 9/30/2004
Rosiglitazone (Avandia) and Pioglitazone (Actos) - Stronger Warnings about Heart Failure 8/15/2007
Rosiglitazone (Avandia) - Possible Association with Ischemic Cardiovascular Events - UPDATED 11/15/2007
Rosiglitazone (Avandia/Avandamet/Avandaryl) 5/increase risk of fractures 2/23/2007
Rosiglitazone - New Onset or Worsening Macular Edema 1/12/2006
Rosuvastatin (Crestor) - Myopathy and Rhabdomyolysis in Asian-Americans at 40 mg Dose 3/3/2005
Rotigotine Transdermal Systems Patch 04/10/2008
Salagen (pilocarpine) and Selegiline (Eldepryl) Name Confusion 03/03/2006
Salivart Oral Moisturizer Recall 3/7/2007
Sanofi-Aventis Medications Stolen – Verify Drug Pedigrees 07/27/2009
Saquinavir (Fortovase/Invirase) plus Ritonavir (ritonavir boosted saquinavir) interacts with rifampin - increased liver toxicity reported 2/10/2005
Sargramostim (Leukine) Liquid Formulation Withdrawn from Market; Special Access Program for Powder Formulation 03/25/2008
Sedative-Hypnotic Labeling Revisions 3/15/2007
Selegiline (Eldepryl) and Salagen (pilocarpine) Name Confusion 03/03/2006
Seroquel (quetiapine) 25 mg tablet recall Lot 3446J 5/5/2004
Serotonin Syndrome With Triptans Plus SSRIs or SNRIs 7/20/2006
Simvastatin/Ezetimibe (Vytorin) and Increased Risk for Cancer - Ongoing Safety Review 08/21/2008
Simvastatin products (Zocor, Zetia, Simcor, generic) and Amiodarone (Cordarone, Pacerone, generic) - Potentially Serious Interaction 08/11/2008
Sirolimus (Rapamune®) – Safety in Liver Transplant Patients 06/15/2009
Sitagliptin (Januvia) and sitagliptin/metformin (Janumet) – Reports of Acute Pancreatitis 09/29/2009
Sodium Chromate Cr-51 Injection Recall 07/13/2009
Sodium Phosphate (Oral) Products for Bowel Cleansing - Renal Adverse Effects 12/12/2008
Sodium Polystyrene Sulfonate - Recall Due to Contamination with Yeast 07/17/2008
SSRI Treatment During Pregnancy 7/20/2006
STARCAPS Diet System Capsules May Contain Bumetanide 12/01/2008
STDs: Unapproved and Misbranded Drugs for Prevention and Treatment of Marketed over the Internet 03/07/2008
Stealth Powdered Dietary Supplements – Recall due to possible Salmonella 07/10/2009
Steroid Products Sold Illegally as Dietary Supplements 3/14/2006
Stimulant Medications for Attention-Deficit/Hyperactivity Disorder – Safety Review 06/16/2009
SureStep® Test Strips 1/30/2003
Tacrolimus (Protopic) and Pimecrolimus (Elidel)/Potential Cancer Risk With Topical 1/24/2006
Tamsulosin (Flomax) Associated with Intraoperative Floppy Iris Syndrome 11/23/2005
Tegaserod Maleate (Zelnorm®) 4/28/2004
Tegaserod (Zelnorm) - Discontinued, No Longer Available Through Treatment Investigational New Drug Protocol- UPDATE 4/03/2008
Telithromycin (Ketek) Updated Warnings - updated 3/27/2007
Testosterone Gel Products and Inadvertent Exposure in Children 05/08/2009
Tiagabine (Gabitril) can cause seizures in patients without epilepsy2/23/2005
Tigecycline (Tygacil®) Reformulation 8/8/2007
Tinzaparin - Increased Risk of Mortality - Ongoing Safety Analysis 12/31/2008
Tiotropium (Spiriva) and Risk of Stroke - Ongoing Safety Review 10/08/2008
Tiotropium Bromide (Spiriva) and Formoterol Fumarate (Foradil) Capsules, Correct Use of 03/04/2008
Tipranavir (Aptivus) Associated With Intracranial Hemorrhage 7/6/2006
Tizanidine (Zanaflex) - Contraindicated with Fluvoxamine or Ciprofloxacin 4/12/2007
Topical Anesthetic Agents for Medical and Cosmetic Procedures – Potentially Fatal Adverse Effects UPDATED 01/20/2009
Toprol-XL (metoprolol succinate) extended release tablets name confusion 9/28/2005
“Total Body Formula” and “Total Body Mega Formula”- High Selenium Concentrations UPDATED 04/10/2008
Tramadol injection – Typographical Error in the Handbook on Injectable Drugs 01/05/2009
Transdermal Patches with Metallic Backings – Risk of Burns if Worn During Magnetic Resonance Imaging Scans 03/06/2009
Trastuzumab (Herceptin) and Bacteriostatic Water for Injection Diluent Vials - Potential Vial Damage 07/11/2008
Trastuzumab (Herceptin) Increases Risk of Cardiotoxicity 9/6/2005
Trazodone interactions with CYP3A4 inhibitors & carbamazepine 5/12/2004
Triaminic Vapor Patch Voluntary Recall 8/2/2006
Trimethobenzamide Suppositories - Discontinued Due to Lack of Efficacy 4/9/2007
Tumor Necrosis Factor (TNF) Blocking Agents (adalimumab [Humira], certolizumab pegol [Cimzia], etanercept [Enbrel], golimimumab [Simponi], infliximab [Remicade])—Risk of Delayed Diagnosis of Opportunistic Infections 06/30/2008
Tumor Necrosis Factor (TNF) α Blocking Agents - Increased Risk of Lymphoma and Other Malignancies 10/15/2004
Ultane (sevoflurane) 11/21/2003
Ultram ER Voluntary Recall 01/14/2009
Utah Medicaid Preferred Drug List Update 05/19/2009
Valdecoxib withdrawn/labeling changes for all NSAIDs/Adverse Effects of NSAIDs 4/7/2005
Valdecoxib (Bextra®) cardiovascular risk and severe skin reactions 12/14/2004
Valdecoxib (Bextra) 11/13/2002
Vapor Patch Voluntary Recall - Triaminic Vapor Patch and WellPatch Cough & Cold Soothing Vapor Pads 8/2/2006
Varenicline (Chantix) – Neuropsychiatric Events and Suicidality Warnings added to the Prescribing Information - Update 07/01/2009
Venlafaxine (Effexor®/Effexor XR®) - Overdose Risk 10/30/2006
Venom Hyperdrive dietary supplement contains undeclared sibutramine 01/28/2009
Vecuronium Bromide for Injection Recall by Hospira 02/09/2009
Vicks Sinex Nasal Spray – Recall of Specific Lots by Procter & Gamble 11/20/2009
Viramune (nevirapine)2/2/2004
Warfarin - Pharmacogenomic Labeling Changes 8/20/2007
Warfarin Sodium (Coumadin®) - Patient Medication Guide and Black Box Warning 10/11/2006
Weight Loss Products Containing Undeclared Active Ingredients 07/17/2009
WellPatch Cough & Cold Soothing Vapor Pads Voluntary Recall 8/2/2006
Xenical (orlistat) - FDA Warning about Counterfeit Medications on the Internet 5/3/2007
Xigris 5/increase mortality in single organ dysfunction patients 3/18/2005
Zanaflex (Tizanidine) - Contraindicated with Fluvoxamine or Ciprofloxacin 4/12/2007
Zanamivir (Relenza) – Potentially Fatal if Nebulized 10/9/09
Zenapax (daclizumab) 8/28/2003
Zhen De Shou Dietary Supplement Contains Undeclared Sibutramine 12/01/2008
Ziagen (Abacavir Sulfate) and Combivir (Lamivudine/Zidovudine) - Third Party Tampering 4/12/2007
Zicam Cold Remedy Nasal Products Associated with Loss of Sense of Smell 06/16/2009
Ziprasidone and fluoroquinolones. 12/2003
Zonisamide (Zonegran® and Generics) – Risk of Metabolic Acidosis 02/23/2009
Zyprexa/Name confusion with 2/10/2005
Zyrtec/Name confusion with 2/10/2005