• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Warning Letters 2004

2004 Warning Letters and Untitled Letters to Pharmaceutical Companies 

These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters.  For District Office Warning Letters see the Main FDA FOI Warning Letters Page.  Some of the letters have been redacted or edited to remove confidential information. Click on the links in each month to view the letters in Adobe Acrobat format. [more...]


December 2004
BioequivalenceMDS Pharma ServicesDSI12/21/20041/3/2005
Crestor (rosuvastatin calcium) Tablets AstraZeneca LPDDMAC12/21/200412/22/2004
Foradil Aerolizer (formoterol fumarate inhalation powder) Schering CorporationDDMAC12/09/200412/23/2004
Seasonale (levonorgestrel/ethinyl estradiol) Tablets Barr Research, Inc.DDMAC12/29/200412/30/2004

November 2004
GLP for non-clinical laboratory (Warning Letter)Celsis Laboratory GroupDSI11/29/20041/10/2005
Micardis (telmisartan) Boehringer IngelheimDDMAC11/24/200411/30/2004
Pamine (methscopolamine bromide) (Warning Letter) Bradley PharmaceuticalsDDMAC11/9/200411/17/2004
Tramadol hydrochloride tablets Mallinckrodt, Inc.DDMAC11/1/200411/15/2004
Viagra (sildenafil citrate) Tablets PfizerDDMAC11/10/200411/15/2004

October 2004
Kaletra (lopinavir/ritonavir) Capsules and Oral Suspension Abbott LaboratoriesDDMAC10/29/200411/2/2004

September 2004
Atrovent (ipratropium bromide) Inhalation Aerosol and Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol (Warning Leter) Boehringer Ingelheim Pharmaceuticals, Inc.DDMAC9/23/20049/24/2004

Duragesic (fentanyl transdermal system) (Warning Letter)

Janssen Pharmaceutica

Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkles (Warning Letter) Ortho-McNeil Pharmaceutical, IncDDMAC9/15/20049/22/2004
Viadur (leuprolide acetate implant) (Warning Letter) Alza CorporationDDMAC9/21/20049/28/2004
Viramune (nevirapine) Tablets and Viramune (nevirapine) Oral SuspensionBoehringer Ingelheim Pharmaceuticals, Inc.DDMAC9/22/20049/22/2004

August 2004

Cubicin (daptomycin for injection) (Warning Letter)

Cubist Pharmaceuticals

Site Inspection (Warning Letter)Bigmar-Bioren SACompliance8/3/20048/6/2004

June 2004
Domperidone (Warning Letter)Axium Healthcare PharmacyCompliance6/7/20046/7/2004
Domperidone (Warning Letter)Drugs Are Us, Inc. DBA Hopewell PharmacyCompliance6/7/20046/7/2004
Domperidone (Warning Letter)Peoples Pharmacy, Inc.Compliance6/7/20046/7/2004
Domperidone (Warning Letter)Spectrum Chemicals & Laboratory ProductsCompliance6/7/20046/7/2004
DomperidoneLine Avenue PharmacyCompliance6/7/20046/7/2004
Norvir (ritonavir capsules) (Warning Letter)Abbot LaboratoriesDDMAC6/10/20046/10/2004
Paxil CR (paroxetine HCl)GlaxoSmithKlineDDMAC6/20046/10/2004

May 2004
MUSE (alprostadil) (Warning Letter)VIVUS, Inc.DDMAC5/25/20045/27/2004
Prograf. (tacrolimus) (Warning Letter)Fujisawa Healthcare, Inc.DDMAC5/7/20045/13/2004

April 2004
Diovan (Valsartan) (Warning Letter)NovartisDDMAC4/21/20044/29/2004
BioequivalenceMDS Pharma ServicesDSI4/26/20045/7/2004
Risperdal (risperidone) (Warning Letter)JanssenDDMAC4/19/20044/29/2004
Zyrtec-D 12 HourPfizerDDMAC4/22/20044/29/2004

March 2004
Effexor, Effexor XR Wyeth PharmaceuticalsDDMAC3/18/20042/26/2004

February 2004
Bexxar (tositumomab and iodine I 131 tositumomab) (Warning LetterCorixa CorporationDDMAC3/16/20043/19/2004
Facility Inspection (Warning Letter)Shanghai Medical, Ltd.DMPQ2/10/20042/27/2004

Prescription Drug Importation

(Warning Letter)

Discount Prescriptions from Canada, Inc.Compliance2/18/20042/19/2004

January 2004
API Site Inspection (Warning Letter)Delta Synthetic Co.Compliance1/5/20045/19/2004
API Site Inspection (Warning Letter)Aliachem A.S.Compliance1/15/20045/19/2004

Prescription Drug Importation

(Warning Letter)

  • Expedite-RX
  • SPC Global Technologies, Ltd.
  • Employer Health Options, Inc.

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.  If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly.  Inquiries to FDA should be sent to:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857