Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Safety

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
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English