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2005 Safety Alerts for Human Medical Products

Items in the following lists are in alphabetical order. Click "Date Issued" to re-order the items in a list by date. Click "Product Name" to re-order the items alphabetically.

Biologics (CBER)

Product NameDate Issued/Updated
Albumin Administration in Critically Ill Patients [ARCHIVED] 05/18/2005
Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135) [ARCHIVED] 10/03/2005
NovoSeven Coagulation Factor VIIa (Recombinant) [ARCHIVED] 12/01/2005
Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products [ARCHIVED] 11/10/2005

Special Nutritional Products and Cosmetics

Product NameDate Issued/Updated
Alcohol-Free Mouthwash and Hygiene Kits by Medline [ARCHIVED] 08/29/2005
Diabetisource AC [ARCHIVED] 11/17/2005
Liqiang 4 Dietary Supplement Capsules [ARCHIVED] 07/05/2005
Salus Corporation Shampoo Caps [ARCHIVED] 11/01/2005
Similac Advance with Iron powdered infant formula [ARCHIVED] 02/16/2005
TMM brand Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer [ARCHIVED] 05/20/2005

Drugs and Therapeutic Biological Products (CDER)

Product NameDate Issued/Updated
Able Laboratories Products - Recall of all Manufactured Drugs [ARCHIVED] 06/01/2005
Accutane and Isotretinoin [ARCHIVED] 08/12/2005
Adderall XR (amphetamine) [ARCHIVED] 02/10/2005
Advair Diskus (fluticasone propionate & salmeterol inhalation powder) [ARCHIVED] 11/18/2005
Agrylin (anagrelide hydrochloride) [ARCHIVED] 02/09/2005
Amevive (alefacept) [ARCHIVED] 11/10/2005
Antidepressant Medications in Adults: Public Health Advisory [ARCHIVED] 07/08/2005
Aranesp (darbepoetin alfa) [ARCHIVED] 12/01/2005
Aranesp (darbepoetin alfa) Jan 2005 [ARCHIVED] 01/14/2005
Aredia (pamidronate disodium), Zometa (zoledronic acid) [ARCHIVED] 05/18/2005
Atypical Antipsychotic Drugs [ARCHIVED] 04/11/2005
Avandamet (rosiglitazone maleate + metformin hydrochloride) Paxil CR (paroxetine hydrochloride) [ARCHIVED] 03/08/2005
Avastin (bevacizumab) Jan 2005 [ARCHIVED] 01/06/2005
Avinza (morphine sulfate extended-release capsules) [ARCHIVED] 11/03/2005
Avonex (interferon beta-1a) [ARCHIVED] 03/16/2005
Betaseron (interferon beta-1b) [ARCHIVED] 04/22/2005
Bextra (valdecoxib) June 2005 [ARCHIVED] 06/15/2005
Bextra (valdecoxib) Apr 2005 [ARCHIVED] 04/07/2005
Celebrex (celecoxib) June 2005 [ARCHIVED] 06/15/2005
Celebrex (celecoxib) Apr 2005 [ARCHIVED] 04/07/2005
Celexa (citalopram) Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications [ARCHIVED] 07/08/2005
Children's Tylenol Meltaways - 80 Mg, Children's Tylenol Softchews - 80 Mg, Jr. Tylenol Meltaways - 160 Mg [ARCHIVED] 06/03/2005
Cialis (Tadalafil) [ARCHIVED] 07/08/2005
Cordarone (amiodarone HCl) [ARCHIVED] 01/10/2005
Counterfeit Drugs Purchased in Mexico [ARCHIVED] 05/11/2005
Counterfeit "Lipitor" Sold in the United Kingdom [ARCHIVED] 08/02/2005
COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) [ARCHIVED] 06/15/2005
COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs NSAIDs [ARCHIVED] 04/07/2005
Crestor (rosuvastatin calicum) [ARCHIVED] 03/02/2005
Cylert and generic pemoline products [ARCHIVED] 10/24/2005
Cymbalta (duloxetine) Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications [ARCHIVED] 07/08/2005
Cymbalta (duloxetine hydrochloride) Oct 2005 [ARCHIVED] 10/17/2005
Dextromethorphan [ARCHIVED] 05/23/2005
Duragesic (fentanyl transdermal system) [ARCHIVED] 07/08/2005
Effexor (venlafaxine) [ARCHIVED] 07/08/2005
Elidel (pimecrolimus), Protopic (tacrolimus) [ARCHIVED] 03/10/2005
Epogen (epoetin alfa) Dec 2005 [ARCHIVED] 12/01/2005
Erbitux (cetuximab) [ARCHIVED] 09/14/2005
Famotidine Injection, 20 mg/2 mL [ARCHIVED] 04/29/2005
Fentanyl Transdermal (Skin) Patch [ARCHIVED] 07/15/2005
Flomax (tamsulosin HCl) [ARCHIVED] 11/22/2005
Fluorouracil Injection 50mg/mL, (500 mg/10mL Single Dose Vial) [ARCHIVED] 09/27/2005
Fluvoxamine [ARCHIVED] 07/08/2005
Foradil Aerolizer (formoterol fumarate inhalation powder) [ARCHIVED] 11/18/2005
Fortovase (saquinavir soft gelatin capsules), Invirase (saquinavir mesylate capsules and tablets) [ARCHIVED] 02/09/2005
Fraudulent Avian Flu Therapies [ARCHIVED] 12/29/2005
Gabitril (tiagabine) [ARCHIVED] 02/22/2005
GenTeal Gel and GenTeal GelDrops [ARCHIVED] 11/22/2005
Herceptin (trastuzumab) [ARCHIVED] 08/31/2005
Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland [ARCHIVED] 09/17/2005
Invirase (saquinavir mesylate capsules and tablets), Fortovase (saquinavir soft gelatin capsules) [ARCHIVED] 02/09/2005
Isotretinoin - Accutane and generic isotretinoin [ARCHIVED] 08/12/2005
Iressa (gefitinib) [ARCHIVED] 06/17/2005
Levitra (Vardenafil hydrochloride) [ARCHIVED] 07/08/2005
Lexapro (escitalopram) [ARCHIVED] 07/08/2005
Long-acting Beta2-Adrenergic Agonists [ARCHIVED] 11/18/2005
MBI Distributing, Inc. [Molecular Biologics] Over-The-Counter Eye Drops and Pain-Relieving Drugs [ARCHIVED] 11/30/2005
Methotrexate for Injection (preservative free) [ARCHIVED] 12/13/2005
Methylin CT (Methylphenidate HCl Chewable Tablets) [ARCHIVED] 01/19/2005
Mifeprex (mifepristone) July 2005 [ARCHIVED] 07/19/2009
Miracle II Neutralizer and Miracle II Neutralizer Gel [ARCHIVED] 12/06/2005
Neurontin (gabapentin) [ARCHIVED] 04/25/2005
Natrecor (nesiritide) July 2005 [ARCHIVED] 07/18/2005
Natrecor (nesiritide) May 2005 [ARCHIVED] 05/19/2005
Novantrone (mitoxantrone for injection concentrate) [ARCHIVED] 05/24/2005
NovoLog Mix 70/30, NovoLog insulin aspart (rDNA origin) injection [ARCHIVED] 09/14/2005
NovoLog insulin aspart (rDNA origin) injection [ARCHIVED] 09/14/2005
NeutroSpec (Technetium [99m Tc] fanolesomab) [ARCHIVED] 12/02/2005
Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) [ARCHIVED] 11/14/2005
Palladone (hydromorphone hydrochloride) [ARCHIVED] 07/14/2005
Paroxetine HCl - Paxil and generic paroxetine [ARCHIVED] 12/08/2005
Paxil (paroxetine HCL), Paxil CR Controlled-Release Tablets [ARCHIVED] 09/27/2005
Paxil (paroxetine) [ARCHIVED] 07/08/2005
Paxil CR (paroxetine hydrochloride), Avandamet (rosiglitazone maleate + metformin hydrochloride) [ARCHIVED] 03/08/2005
Perrigo Infants' Oral Drops Containing Enclosed Syringe [ARCHIVED] 08/02/2005
PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution [ARCHIVED] 03/21/2005
Phenergan (promethazine hydrochloride) [ARCHIVED] 02/17/2005
Procrit (epoetin alfa) Dec 2005 [ARCHIVED] 12/01/2005
Protopic (tacrolimus), Elidel (pimecrolimus) [ARCHIVED] 03/10/2005
Prozac (fluoxetine) [ARCHIVED] 07/08/2005
Quality Care Products L.L.C./Able Laboratories Inc. Drugs [ARCHIVED] 06/16/2005
Raptiva (efalizumab) Revised Warnings [ARCHIVED] 07/20/2005
Remeron (mirtazapine) [ARCHIVED] 07/08/2005
Reminyl (galantamine hydrobromide) [ARCHIVED] 04/01/2005
Serevent Diskus (salmeterol xinafoate inhalation powder) [ARCHIVED] 11/18/2005
Serzone (nefazodone) [ARCHIVED] 07/08/2005
Strattera (atomoxetine) Sep 2005 [ARCHIVED] 09/29/2005
Sustiva (efavirenz) Capsules and Tablets [ARCHIVED] 06/10/2005
Tegretol (carbamazepine) [ARCHIVED] 11/10/2005
Tegretol-XR (carbamazepine extended-release) [ARCHIVED] 11/10/2005
Topamax (topiramate) [ARCHIVED] 11/10/2005
Toprol-XL (metoprolol succinate) [ARCHIVED] 11/10/2005
Trecator (ethionamide tablets, USP) Tablets [ARCHIVED] 03/24/2005
Trileptal (oxcarbazepine) Tablets and Oral Solution [ARCHIVED] 04/19/2005
Trypan Blue 0.06% Ophthalmic Solution [ARCHIVED] 08/29/2005
Tysabri (natalizumab) Public Health Advisory [ARCHIVED] 02/28/2005
Viagra (Sildenafil citrate) [ARCHIVED] 07/08/2005
Vioxx (rofecoxib) June 2005 [ARCHIVED] 06/15/2005
Vioxx (rofecoxib), Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) [ARCHIVED] 04/07/2005
Viramune (nevirapine) Jan 2005 [ARCHIVED] 01/19/2005
Wellbutrin (bupropion) [ARCHIVED] 07/08/2005
Xigris [drotrecogin alfa (activated)] Discontinuation of Study [ARCHIVED] 04/28/2005
Xigris [drotrecogin alfa (activated)] Mar 2005 [ARCHIVED] 03/17/2005
Zevalin (ibritumomab tiuxetan) [ARCHIVED] 10/28/2005
Zoloft (sertraline) [ARCHIVED] 07/08/2005
Zometa (zoledronic acid), Aredia (pamidronate disodium) [ARCHIVED] 05/18/2005
Zometa (zoledronic acid) [ARCHIVED] 03/25/2005
ZyPREXA (olanzapine) [ARCHIVED] 02/08/2005

Medical Devices

Product NameDate Issued/Updated
Abbott Diabetes Care Blood Glucose Meters [ARCHIVED] 10/27/2005
Accusure Insulin Syringes 1cc, 28 Gauge 1/2 Inch [ARCHIVED] 11/04/2005
Baxter Healthcare Colleague Volumetric Infusion Pumps [ARCHIVED] 07/21/2005
Baxter Meridian Hemodialyis (HD) Instrument [ARCHIVED] 12/14/2005
Becton Dickinson ProbeTec ET Urine Processsing Kit [ARCHIVED] 02/01/2005
BioMerieux Simplastin HTF Tissue Reagent [ARCHIVED] 05/18/2005
BioMerieux VeriCal Calibrator Set [ARCHIVED] 09/16/2005
Boston Scientific ENTERYX Procedure Kits and Injector Single Packs [ARCHIVED] 10/17/2005
Boston Scientific Hemashield VANTAGE Vascular Grafts [ARCHIVED] 06/28/2005
B-Sure brand One-Step Home Pregnancy Test [ARCHIVED] 03/28/2005
D-TRON adapters, used with D-TRONplus Insulin Pump [ARCHIVED] 08/01/2005
Endologix Powerlink System Delivery Catheters [ARCHIVED] 12/20/2005
Guidant Corporation Cardiac Pacemakers [ARCHIVED] 07/19/2005
Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators [ARCHIVED] 07/18/2005
Boston Scientific Stainless Steel Greenfield Vena Cava Filters [ARCHIVED] 12/06/2005
HeartSine Technologies, Inc. Samaritan Automatic External Defibrillators (AED) [ARCHIVED] 03/21/2005
Home-Use Diagnostic Kits Marketed by Globus Media [ARCHIVED] 02/08/2005
IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride [ARCHIVED] 02/01/2005
Kingswood Laboratories Moi-Stir Oral Swabsticks [ARCHIVED] 04/28/2005
Laerdal CM 100-Heartstart Adapter Cable [ARCHIVED] 05/02/2005
LifeScan, Inc. OneTouch Ultra, InDuo and OneTouch FastTake Blood Glucose Meters [ARCHIVED] 05/18/2005
Medtronic Implantable Defibrillator models [ARCHIVED] 02/15/2005
Medtronic LIFEPAK 500 Automated External Defibrillators [ARCHIVED] 03/02/2005
Metallic Tracheal Stents in Patients with Benign Airway Disorders [ARCHIVED] 08/02/2005
MicroScan Rapid Pos Inoculum Broth [ARCHIVED] 04/19/2005
MRI-Caused Injuries in Patients with Implanted Neurological Stimulators [ARCHIVED] 05/10/2005
MRL Inc. AED20 Automatic External Defibrillators [ARCHIVED] 05/12/2005
Omron 3-Way Instant Thermometers [ARCHIVED] 11/02/2005
Parenteral Maltose, Parenteral Galactose, Oral Xylose-Containing Products [ARCHIVED] 11/10/2005
Prisma Continuous Renal Replacement System [ARCHIVED] 08/19/2005
Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands [ARCHIVED] 11/16/2005
Vail 500, 1000, and 2000 Enclosed Bed Systems [ARCHIVED] 03/23/2005
Vapotherm 2000i Respiratory Gas Administration Device [ARCHIVED] 12/20/2005

Page Last Updated: 12/30/2014
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