Warning Letters 2007

2007 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 links for each month to view the letters in Adobe Acrobat format. [more...]

 

December 2007

Product/Issue	Company/Individual	Division	Released	Posted
Effexor XR (venlafaxine HCl) Tablets (Warning Letter) Promotional Material	Wyeth Pharmaceuticals Inc.	DDMAC	12/10/2007	12/14/2007
Lindane Shampoo (Warning Letter) Promotional Material	Morton Grove Pharmaceuticals, Inc.	DDMAC	12/14/2007	1/9/2008

November 2007

Product/Issue	Company/Individual	Division	Released	Posted
Natrecor Promotional Material	Scios Inc	DDMAC	11/6/2007	11/7/2007
TYKERB (lapatinib) Tablets Promotional Material	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
Clinical Investigator (Warning Letter)	Surendra Chaganti, M.D.	DSI	10/26/2007	2/15/2008
Clinical Investigator (Warning Letter)	Alan Rappaport, MD	DSI	10/26/2007	10/26/2007
Sponsor-Applicant-Monitor-Clincal Research Organization(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) Promotional Letter	Eli Lilly & Company	DDMAC	9/21/2007	10/2/2007
Clinical Investigator (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) Promotional Material	Novartis Pharmaceuticals Corporation	DDMAC	8/8/2007	8/14/2007

July 2007

Product/Issue	Company/Individual	Division	Released	Posted
Clinical Investigator (Warning Letter)	David Linden, M.D.	DSI	7/3/2007	8/10/2007
Geodon (ziprasidone mesylate) for Injection Promotional Material	Pfizer Inc.	DDMAC	7/16/2007	8/13/2007
Solaraze (dicolofenac sodium) Promotional Material	Doak Dermatologics	DDMAC	7/17/2007	7/18/2007

June 2007

Product/Issue	Company/Individual	Division	Released	Posted
Sponsor/Investigator (Warning Letter)	Frank A. Wingrove, D.D.S	DSI	6/22/2007	8/10/2007
GLP for non-clinical laboratory studies (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) Promotional Material	Enzon Pharmaceuticals	DDMAC	5/21/2007	5/24/2007
Clinical Investigator Warning Letter	David Linden, MD	DSI	5/22/2007	7/7/2009
Acular LS (ketorlac tromethamine) ophthalmic solution (Warning Letter) Promotional Material	Allergan, Inc.	DDMAC	5/25/2007	5/30/2007
Clinical Investigator (Warning Letter)	David H. Vesole, M.D., Ph.D.	DSI	5/30/2007	6/11/2007
Clindesse (clindamycin phosphate) vaginal cream Promotional Material	KV Pharmaceutical	DDMAC	5/17/2007	5/22/2007
Flonase (fluticasone propionate) Nasal Spray Promotional Material	GlaxoSmithKline	DDMAC	5/7/2007	5/9/2007
Nasonex (mometasone furoate monohydrate Promotional Material	Schering	DDMAC	5/7/2007	5/9/2007

April 2007

Product/Issue	Company/Individual	Division	Released	Posted
Ciprodex (ciprofloxacin) sterile otic suspension (Warning Letter) Promotional Material	Alcon Laboratories	DDMAC	4/20/2007	4/24/2007
Levulan Kerastick (aminolevulinic acid HCl) (Warning Letter) Promotional Material	DUSA Pharmaceuticals, Inc.	DDMAC	4/20/2007	4/26/2007

March 2007

Product/Issue	Company/Individual	Division	Released	Posted
Rozerem (ramelteon) tablets Promotional Material	Takeda Pharmaceuticals North America	DDMAC	3/5/2007	3/8/2007

February 2007

Product/Issue	Company/Individual	Division	Released	Posted
Clinical Investigator (Warning Letter)	Jerry M. Herron, M.D.	DSI	2/13/2007	4/23/2007
Clinical Investigator (Warning Letter)	Robert Michael Murray, M.D.	DSI	2/28/2007	4/23/2007
Clinical Investigator (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) Promotional Material	Cephalon	DDMAC	2/27/2007	3/1/2007

January 2007

Product/Issue	Company/Individual	Division	Released	Posted
Sponsor/Applicant/Monitor/CRO (Warning Letter)	Avlon Industries	DSI	1/19/2007	1/31/2007
Clinical Investigator (Warning Letter)	Lawrence S. Kim, M.D.	DSI	1/16/2007	4/15/2008
Gliadel Wafer (polifeprosan 20 with carmustine implant) Promotional Material	MGI PHARMA, Inc.	DDMAC	1/29/2007	1/31/2007
Evoxac Capsules (cevimeline hydrochloride) (Warning Letter) Promotional Material	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

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