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 month to view the letters in Adobe Acrobat format. [more...]
[2008] 2007
[2006]
[2005]
[2004]
[2003]
[2002]
[2001]
[2000]
[1999]
[1998]
[1997] |
December 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Effexor XR (venlafaxine HCl) Tablets (Warning Letter)
|
Wyeth Pharmaceuticals Inc. |
DDMAC |
12/10/2007 |
12/14/2007 |
Lindane Shampoo (Warning Letter)
|
Morton Grove Pharmaceuticals, Inc. |
DDMAC |
12/14/2007 |
1/9/2008 |
November 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Natrecor
|
Scios Inc |
DDMAC |
11/6/2007 |
11/7/2007 |
TYKERB (lapatinib) Tablets
|
GlaxoSmithKline |
DDMAC |
11/21/2007 |
11/26/2007 |
October 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Site Inspection (Warning Letter) |
Northeast General Pharmaceutical Factory |
DMPQ |
10/31/2007 |
11/1/2007 |
BMIS Inspection (Warning Letter) |
Surendra Chaganti, M.D. |
DSI |
10/26/2007 |
2/15/2008 |
BMIS Inspection (Warning Letter) |
Sanofi-Aventis U.S. |
DSI |
10/23/2007 |
10/24/2007 |
September 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Cymbalta (duloxetine hydrochloride)
|
Eli Lilly & Company |
DDMAC |
9/21/2007 |
10/2/2007 |
BMIS Inspection (Warning Letter) |
Robert J. Amato, D.O. |
DSI |
9/18/2007 |
4/15/2008 |
Site Inspection (Warning Letter) |
Kunshan Chemical & Pharmaceutical Company |
DMPQ |
9/6/2007 |
9/20/2007 |
August 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Exelon (rivastigmine tartrate) Capsules and Oral Solution (Warning Letter)
|
Novartis Pharmaceuticals Corporation |
DDMAC |
8/8/2007 |
8/14/2007 |
July 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
BMIS Inspection (Warning Letter) |
David Linden, M.D. |
DDMAC |
7/3/2007 |
8/10/2007 |
Geodon (ziprasidone mesylate) for Injection
|
Pfizer Inc. |
DDMAC |
7/16/2007 |
8/13/2007 |
Solaraze (dicolofenac sodium)
|
Doak Dermatologics |
DDMAC |
7/17/2007 |
7/18/2007 |
June 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
BMIS Inspection (Warning Letter) |
Frank A. Wingrove, D.D.S |
DSI |
6/22/2007 |
8/10/2007 |
BMIS Inspection (Warning Letter) |
Sitek Research Laboratories |
DSI |
6/25/2007 |
7/6/2007 |
May 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Abelcet (Amphotericin B Lipid Complex Injection) (Warning Letter)
|
Enzon Pharmaceuticals |
DDMAC |
5/21/2007 |
5/24/2007 |
Acular LS (ketorlac tromethamine) ophthalmic solution (Warning Letter)
|
Allergan, Inc. |
DDMAC |
5/25/2007 |
5/30/2007 |
BMIS Inspection (Warning Letter) |
David H. Vesole, M.D., Ph.D. |
DSI |
5/30/2007 |
6/11/2007 |
Clindesse (clindamycin phosphate) vaginal cream
|
KV Pharmaceutical |
DDMAC |
5/17/2007 |
5/22/2007 |
Flonase (fluticasone propionate) Nasal Spray
|
GlaxoSmithKline |
DDMAC |
5/7/2007 |
5/9/2007 |
Nasonex (mometasone furoate monohydrate)
|
Schering |
DDMAC |
5/7/2007 |
5/9/2007 |
April 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Ciprodex (ciprofloxacin) sterile otic suspension (Warning Letter)
|
Alcon Laboratories |
DDMAC |
4/20/2007 |
4/24/2007 |
Levulan Kerastick (aminolevulinic acid HCl) (Warning Letter)
|
DUSA Pharmaceuticals, Inc. |
DDMAC |
4/20/2007 |
4/26/2007 |
March 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Rozerem (ramelteon) tablets
|
Takeda Pharmaceuticals North America |
DDMAC |
3/5/2007 |
3/8/2007 |
February 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
BMIS Inspection (Warning Letter) |
Jerry M. Herron, M.D. |
DSI |
2/13/2007 |
4/23/2007 |
BMIS Inspection (Warning Letter) |
Robert Michael Murray, M.D. |
DSI |
2/28/2007 |
4/23/2007 |
BMIS Inspection (Warning Letter) |
Hollis J.C. Underwood, M.D. |
DSI |
2/15/2007 |
4/23/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Actavis Totowa LLC |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Anabolic Laboratories |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Bio Pharm Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Breckenridge Pharmaceutical Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Centrix Pharmaceutical Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
DRX Pharmaceutical Consultants Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
DSC Laboratories |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Excellium Pharmaceutical Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Ferndale Laboratories Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Harvard Drug Group |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
IVAX Pharmaceuticals Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Kaiser Foundation Hosptials |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Lini Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Murfreesboro Pharmaceutical Nursing Supply |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Nucare Pharmaceuticals Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Qualitest Pharmaceuticals, Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Sandoz Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
SDA Laboratories |
DLNDC |
2/26/2006 |
3/20/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
United Research Laboratories Inc. and Mutual Pharmaceutical Company |
DLNDC |
2/26/2007 |
3/1/2007 |
Marketing an unapproved new drug - ergotamine tartrate |
Vintage Pharmaceuticals Inc. |
DLNDC |
2/26/2007 |
3/1/2007 |
Site Inspection (Warning Letter) |
Niagra Pharmaceuticals |
DMPQ |
2/23/2007 |
3/1/2007 |
Provigil (Warning Letter)
|
Cephalon |
DDMAC |
2/27/2007 |
3/1/2007 |
January 2007 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
BMIS Inspection (Warning Letter) |
Avlon Industries |
Compliance |
1/19/2007 |
1/31/2007 |
BMIS Inspection (Warning Letter) |
Lawrence S. Kim, M.D. |
DSI |
1/16/2007 |
4/15/2008 |
Gliadel Wafer (polifeprosan 20 with carmustine implant)
|
MGI PHARMA, Inc. |
DDMAC |
1/29/2007 |
1/31/2007 |
Evoxac Capsules (cevimeline hydrochloride) (Warning Letter)
|
Daiichi Sankyo, Inc. |
DDMAC |
1/12/2007 |
1/19/2007 |
Pharmacy Compounding of Domperidone
(Warning Letter) |
Kalchem International, Inc. |
DNDLC |
1/8/2007 |
1/9/2008 |
The letters are arranged in chronological order by month. Click on the product name to
view the letters in Adobe Acrobat (PDF) format. Go here for further information about Adobe Acrobat and download instructions.