FDA Alerts Archive for 2007

January 4, 2007

• Tamiflu (oseltamivir phosphate) - Jan 4, 2007

January 12, 2007

• Cough and Cold Medications in Children Less Than Two Years of Age - Jan 12, 2007

January 25, 2007

• Liviro3

January 27, 2007

• Aranesp (darbepoetin alfa) - Jan 27, 2007

February 1, 2007

• Lucentis (ranibizumab injection)

February 7, 2007

• Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL Medication Errors

February 12, 2007

• Ketek (telithromycin) - Feb 12, 2007

February 13, 2007

• Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) - Feb 13, 2007

February 16, 2007

• Ambien (zolpidem tartrate)
• Ativan (lorazepam)
• Erythropoiesis Stimulating Agents
• Lexapro (escitalopram oxalate)
• Xanax (alprazolam)

February 20, 2007

• Avandamet (rosiglitazone maleate and metformin hydrochloride)
• Avandaryl (rosiglitazone maleate and glimepiride)
• Avandia (rosiglitazone maleate) - Feb 20, 2007

February 21, 2007

• Xolair (omalizumab)

February 22, 2007

• CellCept (mycophenolate mofetil) - Feb 22, 2007

February 24, 2007

• Baraclude (entecavir) Tablets and Oral Solution

March 2, 2007

• Ergotamine tartrate

March 8, 2007

• Duetact (pioglitazone and glimepiride)

March 9, 2007

• Actimmune (Interferon Gamma 1-b)
• Actos (pioglitazone)
• ACTOplus met (pioglitazone and metformin hydrochloride
• Aranesp (darbepoetin alfa) - Mar 9, 2007
• Epogen (epoetin alfa) - Mar 9, 2007
• Procrit (epoetin alfa) - Mar 19, 2007

March 14, 2007

• Doral (quazepam)
• Halcion (triazolam)
• Lunesta (eszopiclone)
• Placidyl (ethchlorvynol)
• Prosom (estazolam)
• Restoril (temazepam)
• Rozerem (ramelteon)
• Seconal (secobarbital sodium)
• Sonata (zaleplon)
• Sedative-hypnotic drug products
• Ambien, Ambien CR (zolpidem tartate)
• Butisol sodium Carbrital (pentobarbital and carbromal)
• Dalmane (flurazepam hydrochloride)

March 16, 2007

• Zyvox (linezolid)
• Rhino Max (Rhino V Max) supplement product

March 19, 2007

• V.MAX supplement product

March 28, 2007

• Accutane (isotretinoin) - Mar 28, 2007
• DermaFreeze365 Products

March 29, 2007

• Permax (pergolide) and generic equivalents

March 30, 2007

• Zelnorm (tegaserod maleate)

April 6, 2007

• Trimethobenzamide hydrochloride suppositories

April 10, 2007

• Combivir (lamivudine and zidovudine) Tablets
• Ziagen (abacavir sulfate) Tablets

April 11, 2007

• Zanaflex (tizanidine hydrochloride) Tablets and Capsules

April 21, 2007

• Avastin (bevacizumab) - Apr 21, 2007

April 25, 2007

• PharmaFab Inc., manufacturer and distributor of prescription and over-the-counter drug products

May 2, 2007

• Antidepressant Medication Products
• Colchicine Compounded Injectable Products (Posted 05/02/2007)

May 7, 2007

• Glycerin compounded products

May 10, 2007

• Energy Max
• OxyContin, Illegal Promotion by Manufacturer
• True Man

May 17, 2007

• NBTY Shark Cartilage Capsules

May 21, 2007

• Caffeine Citrated, Powder, Purified
• Avandia (rosiglitazone) - May 21, 2007

May 22, 2007

• Exjade (deferasorix) Tablets For Oral Suspension
• Exjade (deferasirox) Tablets For Oral Suspension

May 23, 2007

• Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance

May 25, 2007

• Guaifenesin (Unapproved) Timed-Release Drug Products

May 29, 2007

• Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron

June 1, 2007

• Toothpaste Imported From China May Contain Diethylene Glycol

June 15, 2007

• Long Weekend Dietary Supplement
• Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) - June 15, 2007
• Propofol (marketed as Diprivan and generic products)
• Diprivan (propofol)

June 28, 2007

• Colistimethate (marketed as Coly-Mycin M and generic products)

July 5, 2007

• Invanz (ertapenem sodium) Injection
• Rocephin (ceftriaxone sodium) for Injection

August 9, 2007

• Nexium (esomeprazole)
• Omeprazole (marketed as Prilosec and generic products)
• Omeprazole + Sodium Bicarbonate (marketed as Zegerid)
• Cholestrix
• Red Yeast Rice
• Red Yeast Rice/Policosonal Complex

August 14, 2007

• Kaletra (lopinavir/ritonavir) Oral Solution
• Avandia (rosiglitazone maleate) Tablets - August 14, 2007
• Actos (pioglitazone hydrochloride) Tablets
• Avandaryl (rosiglitazone maleate and glimepiride) Tablets
• Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
• Duetact (pioglitazone hydrochloride and glimepride) Tablets

August 15, 2007

• Nonprescription Cough and Cold Medicine Use in Children

August 16, 2007

• Warfarin (marketed as Coumadin)

August 17, 2007

• Codeine Products Used By Nursing Mothers

August 21, 2007

• METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules

September 7, 2007

• Zencore Tabs

September 10, 2007

• Viracept (nelfinavir mesylate)

September 13, 2007

• Fentora (fentanyl buccal tablet)

September 17, 2007

• Haloperidol (Haldol, Haldol decanoate, and Haldol lactate)

September 21, 2007

• Axcil Dietary Supplement
• Baby's Bliss Gripe Water, Apple flavor
• Desirin Dietary Supplement

September 28, 2007

• Hydrocodone in Unapproved Prescription Products

October 16, 2007

• Byetta (exenatide)

October 18, 2007

• Cialis (tadalafil) - Oct 18, 2007
• Levitra (vardenafil)
• Revatio (sildenafil)
• Viagra (sildenafil)

October 24, 2007

• Provigil (modafinil) Tablets

October 25, 2007

• Aprotinin Injection (marketed as Trasylol)

October 29, 2007

• CellCept (mycophenolate mofetil) - Oct 29, 2007

November 1, 2007

• NC Solution (antifungal product)
• Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microsp

November 5, 2007

• Trasylol (aprotinin injection)

November 8, 2007

• Erythropoiesis Stimulating Agents:Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

November 14, 2007

• Avandia (rosiglitazone maleate) Tablets - November 14, 2007
• Cefepime (marketed as Maxipime)

November 19, 2007

• Age Intervention Eyelash

November 20, 2007

• Chantix (Varenicline)

November 26, 2007

• Encore Supplement Tablets

November 27, 2007

• Myfortic (mycophenolic acid) Delayed Release Tablets

December 4, 2007

• Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)

December 11, 2007

• Omeprazole (marketed as Prilosec and generic products), Esomeprazole (marketed as Nexium)

December 12, 2007

• Radio Frequency Ablation Devices
• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics)

December 13, 2007

• Electric Dental Handpieces
• Exjade (deferasirox)

December 14, 2007

• PedvaxHIB (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)), COMVAX (Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine)

December 18, 2007

• Nonoxynol 9 (N9) OTC Contraceptive Products

December 21, 2007

• Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes)
• Fentanyl Transdermal System (marketed as Duragesic and generics)

December 26, 2007

• Bayer Diabetes Care Contour Test Strips (TS)
• Cardinal Health Alaris Pump Module

December 31, 2007

• Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan)