Warning Letters 2005

2005 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 2005
GLP for non-clinical laboratory studies (Warning Letter)IIT ResearchDSI12/5/100512/20/2005
Clinical Investigator (Warning Letter)Raymond E. Tidman, M.D.DSI12/19/20051/11/2006
Zevalin (ibritumomab tiuxetan) Biogen Idec Inc.DDMAC12/15/20052/8/2006
November 2005
"Barbec Basics Natural Progesterone Cream" (Warning Letter)
One Life USADNDLC11/9/100511/10/2005
"HMS Queen's Progesterone" and "HMS King's Progesterone"   (Warning Letter) PDF or HTMLHMS CrownDNDLC11/9/200511/10/2005
Vitrase (hyaluronidase injection) ISTA Pharmaceuticals, IncDDMAC11/2/200511/3/2005
Z-LABS Progesterone Cream (Warning Letter) PDF or HTMLBio-HealthDNDLC11/9/200511/10/2005
Zyflo Filmtab (zileuton tablets) (Warning Letter) Critical Therapeutics, Inc.DDMAC11/8/200511/9/2005
October 2005
Clinical Investigator (Warning Letter)Dr. Spencer JonesDSI10/27/200511/2/2005
September 2005
Calcitriol Injection (Warning Letter) NephrxDDMAC9/29/20059/30/2005
Cymbalta (duloxetine) Eli LillyDDMAC9/9/200511/9/2005
Lumigan (bimatoprost) ophthalmic solution (Warning Letter) Allergan, Inc.DDMAC9/6/20059/8/2005
Travatan (travoprost ophthalmic solution) Alcon Research, Ltd.DDMAC9/22/20059/23/2005
August 2005
Nipent (pentostatin) for Injection (Warning Letter)SuperGen, Inc.DDMAC8/18/20058/22/2005
Site Inspection (Warning Letter)Similasan AGDMPQ8/16/20059/7/2005
July 2005
Domperidone (Warning Letter)Cape DrugsDNDLC7/11/20058/10/2005
Fuzeon (enfuvirtide) for InjectionHoffman-La Roche, Inc.DDMAC7/15/20057/18/2005
GLP for non-clinical laboratory studies (Warning Letter)Litron Laboratories, Ltd.DSI7/1/20057/12/2005
Quadramet (Samarium SM 153 Lexidronam) Injection (Warning Letter) Cytogen CorporationDDMAC7/18/20057/19/2005
Site Inspection (Warning Letter)ACS DobfarDMPQ7/21/20057/28/2005
Survanta (beractant) intreacheal suspension Abbott LaboratoriesDDMAC7/15/20057/19/2005
Tracleer (bosentan) Tablets (Warning Letter)Actelion Pharmaceuticals US, Inc.DDMAC7/20/20057/26/2005
ZYVOX (linezolid) injection, tablets, and oral suspension (Warning Letter) Pfizer, Inc.DDMAC7/20/20057/26/2005
June 2005
Sponsor-Investigator (Warning Letter)Clark Bishop, M.D.DSI6/7/20056/22/2005
Lidoderm (Lidocaine Patch 5%) (Warning Letter) Endo Pharmaceuticals Inc.DDMAC6/28/20056/29/2005

Strattera (atomoxetine HCl)

Eli Lilly and Company

VisionBlue (trypan blue ophthalmic solution) (Warning Letter) Dutch Ophthalmic USADDMAC6/28/20056/29/2005
May 2005
Zoloft Pfizer PharmaceuticalsDDMAC5/6/20055/6/2005
Ferrlecit Watson PharmaceuticalsDDMAC5/5/20055/6/2005
April 2005
CIPRO HC OTIC (Warning Letter) Alcon Laboratories, Inc.DDMAC4/27/20054/28/2005
Levitra (vardenafil HCl) Tablets Bayer Pharmaceuticals, Corp.DDMAC4/13/20054/15/2005
Remodulin (treprostinil sodium) Injection (Warning Letter) United Therapeutics CorporationDDMAC4/13/20054/14/2005
Zyrtec (cetirizine HCl) (Warning Letter) Pfizer, Inc.DDMAC4/13/20054/15/2005
March 2005
Aggrenox (aspirin/extended-release dipyridamole) CapsulesBoehringer Ingelheim Pharmaceuticals, Inc.DDMAC3/22/20053/23/2005
Crestor (rosuvastatin calcium) AstraZeneca Pharmaceuticals LPDDMAC3/8/20053/14/2005
Tindamax (tinidazole tablets) (Warning Letter) Presutti Laboratories, Inc.DDMAC3/30/20054/14/2005
February 2005
Enbrel (etanercept) (Warning Letter) AmgenDDMAC2/18/20052/18/2005
Remicade CentocorDDMAC2/11/20052/14/2005
Site Inspection (Warning Letter)Germiphene CorporationDMPQ2/15/20053/21/2005
January 2005
GLP for non-clinical laboratory studies (Warning Letter)Gene LogicDSI1/28/20052/11/2005
Celebrex & Bextra Pfizer Inc.DDMAC1/10/20051/12/2005
Coreg (carvedilol) Tablets (Warning Letter) GlaxoSmithKlineDDMAC1/31/20052/3/2005

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


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