FDA Alerts Archive for 2005

January 10, 2005

• Cordarone (amiodarone HCl)

January 14, 2005

• Aranesp (darbepoetin alfa) - Jan 14, 2005

January 19, 2005

• Methylin CT (Methylphenidate HCl Chewable Tablets)
• Viramune (nevirapine) - Jan 19, 2005

February 9, 2005

• Agrylin (anagrelide hydrochloride)
• Fortovase (saquinavir soft gelatin capsules)
• Invirase (saquinavir mesylate capsules and tablets)

February 10, 2005

• Adderall XR (amphetamine)

February 17, 2005

• Phenergan (promethazine hydrochloride)

February 22, 2005

• Gabitril (tiagabine)

February 28, 2005

• Tysabri (natalizumab) - Feb 2, 2005

March 2, 2005

• Crestor (rosuvastatin) - Mar 2, 2005

March 8, 2005

• Paxil CR (paroxetine hydrochloride)

March 10, 2005

• Elidel (pimecrolimus)
• Protopic (tacrolimus)

March 16, 2005

• Avonex (interferon beta-1a)

March 17, 2005

• Xigris [drotrecogin alfa (activated)] - Mar 17, 2005

March 21, 2005

• PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution

March 24, 2005

• Trecator (ethionamide tablets, USP) Tablets

March 25, 2005

• Zometa (zoledronic acid) - Mar 25, 2005

April 1, 2005

• Reminyl (galantamine hydrobromide) - Apr 1, 2005

April 7, 2005

• Bextra (valdecoxib - Apr 7, 2005
• Celebrex (celecoxib) - Apr 7, 2005
• COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Vioxx (rofecoxib) - Apr 7, 2005

April 11, 2005

• Atypical Antipsychotic Drugs

April 19, 2005

• Trileptal (oxcarbazepine) Tablets and Oral Solution

April 22, 2005

• Betaseron (interferon beta-1b)

April 25, 2005

• Neurontin (gabapentin)

April 28, 2005

• Xigris [drotrecogin alfa (activated)] - Apr 28, 2005

April 29, 2005

• Famotidine Injection, 20 mg/2 mL

May 11, 2005

• Counterfeit Drugs Purchased in Mexico

May 18, 2005

• Aredia (pamidronate disodium)
• Zometa (zoledronic acid) - May 18, 2005

May 19, 2005

• Natrecor (nesiritide) - May 19, 2005

May 23, 2005

• Dextromethorphan

May 24, 2005

• Novantrone (mitoxantrone for injection concentrate)

June 1, 2005

• Able Laboratories Products

June 3, 2005

• Children's Tylenol Meltaways - 80 Mg, Children's Tylenol Softchews - 80 Mg, and Jr. Tylenol Meltaways - 160 Mg

June 10, 2005

• Sustiva (efavirenz) Capsules and Tablets

June 15, 2005

• Bextra (valdecoxib) - Jun 15, 2005
• Celebrex (celecoxib) - Jun 15, 2005
• COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Vioxx (rofecoxib) - Jun 15, 2005

June 16, 2005

• Quality Care Products L.L.C./Able Laboratories Inc. Drugs

June 17, 2005

• Iressa (gefitinib)

July 1, 2005

• Antidepressant Medications in Adults: Public Health Advisory

July 8, 2005

• Celexa (citalopram)
• Cialis (Tadalafil) - Jul 8, 2005
• Cymbalta (duloxetine hydrochloride) - Jul 8, 2005
• Duragesic (fentanyl transdermal system) - Jul 8, 2005
• Effexor (venlafaxine)
• Fluvoxamine
• Levitra (Vardenafil hydrochloride)
• Lexapro (escitalopram)
• Paxil (paroxetine)
• Prozac (fluoxetine)
• Remeron (mirtazapine)
• Serzone (nefazodone)
• Viagra (Sildenafil citrate)
• Wellbutrin (bupropion)
• Zoloft (sertraline)

July 14, 2005

• Palladone (hydromorphone hydrochloride)

July 15, 2005

• Fentanyl Transdermal (Skin) Patch

July 18, 2005

• Natrecor (nesiritide) - Jul 18, 2005

July 19, 2005

• Mifeprex (mifepristone) - Jul 19, 2005

July 20, 2005

• Raptiva (efalizumab) - Jun 20, 2005

August 2, 2005

• Counterfeit "Lipitor" Sold in the United Kingdom
• Perrigo Infants’ Oral Drops Containing Enclosed Syringe

August 12, 2005

• Accutane and generic isotretinoin - Aug 12, 2005
• Isotretinoin - Accutane and generic isotretinoin - Aug 12, 2005

August 29, 2005

• Trypan Blue 0.06% Ophthalmic Solution

August 31, 2005

• Herceptin (trastuzumab)

September 14, 2005

• Erbitux (cetuximab)
• NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])
• NovoLog insulin aspart [rDNA origin] injection)

September 17, 2005

• Central Admixture Pharmacy Service (CAPS) of  Lanham, Maryland Injectable Products

September 26, 2005

• Toprol-XL (metoprolol succinate)

September 27, 2005

• Fluorouracil Injection 50mg/mL, (500 mg/10mL Single Dose Vial)
• Paxil (paroxetine HCL) and Paxil CR

September 29, 2005

• Strattera (atomoxetine) - Sep 29, 2005

September 30, 2005

• Topamax (topiramate)

October 17, 2005

• Cymbalta (duloxetine hydrochloride) - Oct 17, 2005

October 24, 2005

• Cylert and generic pemoline products

October 28, 2005

• Zevalin (ibritumomab tiuxetan)

November 3, 2005

• Avinza (morphine sulfate extended-release

November 10, 2005

• Amevive (alefacept)
• Tegretol (carbamazepine)

November 14, 2005

• Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)

November 18, 2005

• Advair Diskus (fluticasone propionate & salmeterol inhalation powder)
• Foradil Aerolizer (formoterol fumarate inhalation powder)
• Long-acting Beta2-Adrenergic Agonists
• Serevent Diskus (salmeterol xinafoate inhalation powder)

November 22, 2005

• Flomax (tamsulosin HCl)
• GenTeal Gel and GenTeal GelDrops

November 30, 2005

• MBI Distributing, Inc. [Molecular Biologics] Over-The-Counter Eye Drops and Pain-Relieving Drugs

December 1, 2005

• Aranesp
• Epogen (epoetin alfa) - Dec 1, 2005
• Procrit (epoetin alfa) - Dec 1, 2005

December 2, 2005

• NeutroSpec (Technetium [99m Tc] fanolesomab)

December 6, 2005

• Miracle II Neutralizer and Miracle II Neutralizer Gel

December 8, 2005

• Paroxetine HCl - Paxil and generic paroxetine

December 13, 2005

• Methotrexate for Injection (preservative free)

December 29, 2005

• Fraudulent Avian Flu Therapies