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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/IssueCompany/IndividualDivisionReleasedPosted

Effexor XR (venlafaxine HCl) Tablets (Warning Letter)

Wyeth Pharmaceuticals Inc.DDMAC12/10/200712/14/2007

Lindane Shampoo (Warning Letter)

Morton Grove Pharmaceuticals, Inc.DDMAC12/14/20071/9/2008

November 2007
Product/IssueCompany/IndividualDivisionReleasedPosted

Natrecor

Scios IncDDMAC11/6/200711/7/2007

TYKERB (lapatinib) Tablets

GlaxoSmithKlineDDMAC11/21/200711/26/2007

October 2007
Product/IssueCompany/IndividualDivisionReleasedPosted
Site Inspection (Warning Letter)Northeast General Pharmaceutical FactoryDMPQ10/31/200711/1/2007
Clinical Investigator (Warning Letter)Surendra Chaganti, M.D.DSI10/26/20072/15/2008
Clinical Investigator
(Warning Letter)
 
Alan Rappaport, MDDSI10/26/200710/26/2007
Sponsor-Applicant-Monitor-Clincal Research Organization(Warning Letter)Sanofi-Aventis U.S.DSI10/23/200710/24/2007

September 2007
Product/IssueCompany/IndividualDivisionReleasedPosted

Cymbalta (duloxetine hydrochloride)

Eli Lilly & CompanyDDMAC9/21/200710/2/2007
Clinical Investigator (Warning Letter)Robert J. Amato, D.O.DSI9/18/20074/15/2008
Site Inspection (Warning Letter)Kunshan Chemical & Pharmaceutical CompanyDMPQ9/6/20079/20/2007

August 2007
Product/IssueCompany/IndividualDivisionReleasedPosted

Exelon (rivastigmine tartrate) Capsules and Oral Solution (Warning Letter)

Novartis Pharmaceuticals CorporationDDMAC8/8/20078/14/2007

July 2007
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)David Linden, M.D.DSI7/3/20078/10/2007

Geodon (ziprasidone mesylate) for Injection

Pfizer Inc.DDMAC7/16/20078/13/2007

Solaraze (dicolofenac sodium)

Doak DermatologicsDDMAC7/17/20077/18/2007

June 2007
Product/IssueCompany/IndividualDivisionReleasedPosted
Sponsor/Investigator (Warning Letter)Frank A. Wingrove, D.D.SDSI6/22/20078/10/2007
GLP for non-clinical laboratory studies (Warning Letter)Sitek Research LaboratoriesDSI6/25/20077/6/2007

May 2007
Product/IssueCompany/IndividualDivisionReleasedPosted

Abelcet (Amphotericin B Lipid Complex Injection) (Warning Letter)

Enzon PharmaceuticalsDDMAC5/21/20075/24/2007

Clinical Investigator

David Linden, MDDSI5/22/20077/7/2009

Acular LS (ketorlac tromethamine) ophthalmic solution (Warning Letter)

Allergan, Inc.DDMAC5/25/20075/30/2007
Clinical Investigator (Warning Letter)David H. Vesole, M.D., Ph.D.DSI5/30/20076/11/2007

Clindesse (clindamycin phosphate) vaginal cream

KV PharmaceuticalDDMAC5/17/20075/22/2007

Flonase (fluticasone propionate) Nasal Spray

GlaxoSmithKlineDDMAC5/7/20075/9/2007

Nasonex (mometasone furoate monohydrate

ScheringDDMAC5/7/20075/9/2007

April 2007
Product/IssueCompany/IndividualDivisionReleasedPosted

Ciprodex (ciprofloxacin) sterile otic suspension (Warning Letter)

Alcon LaboratoriesDDMAC4/20/20074/24/2007

Levulan Kerastick (aminolevulinic acid HCl) (Warning Letter)

DUSA Pharmaceuticals, Inc.DDMAC4/20/20074/26/2007

March 2007
Product/IssueCompany/IndividualDivisionReleasedPosted

Rozerem (ramelteon) tablets

Takeda Pharmaceuticals North AmericaDDMAC3/5/20073/8/2007

February 2007
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)Jerry M. Herron, M.D.DSI2/13/20074/23/2007
Clinical Investigator (Warning Letter)Robert Michael Murray, M.D.DSI2/28/20074/23/2007
Clinical Investigator (Warning Letter)Hollis J.C. Underwood, M.D.DSI2/15/20074/23/2007
Marketing an unapproved new drug - ergotamine tartrateActavis Totowa LLCDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateAnabolic LaboratoriesDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateBio Pharm Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateBreckenridge Pharmaceutical Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateCentrix Pharmaceutical Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateDRX Pharmaceutical Consultants Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateDSC LaboratoriesDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateExcellium Pharmaceutical Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateFerndale Laboratories Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateHarvard Drug GroupDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateIVAX Pharmaceuticals Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateKaiser Foundation HosptialsDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateLini Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateMurfreesboro Pharmaceutical Nursing SupplyDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateNucare Pharmaceuticals Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateQualitest Pharmaceuticals, Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateSandoz Inc.DLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateSDA LaboratoriesDLNDC2/26/20063/20/2007
Marketing an unapproved new drug - ergotamine tartrateUnited Research Laboratories Inc. and Mutual Pharmaceutical CompanyDLNDC2/26/20073/1/2007
Marketing an unapproved new drug - ergotamine tartrateVintage Pharmaceuticals Inc.DLNDC2/26/20073/1/2007
Site Inspection (Warning Letter)Niagra PharmaceuticalsDMPQ2/23/20073/1/2007

Provigil (Warning Letter)

CephalonDDMAC2/27/20073/1/2007

January 2007
Product/IssueCompany/IndividualDivisionReleasedPosted
Sponsor/Applicant/Monitor/CRO (Warning Letter)Avlon IndustriesDSI1/19/20071/31/2007
Clinical Investigator (Warning Letter)Lawrence S. Kim, M.D.DSI1/16/20074/15/2008

Gliadel Wafer (polifeprosan 20 with carmustine implant)

MGI PHARMA, Inc.DDMAC1/29/20071/31/2007

Evoxac Capsules (cevimeline hydrochloride) (Warning Letter)

Daiichi Sankyo, Inc.DDMAC1/12/20071/19/2007
Pharmacy Compounding of Domperidone
(Warning Letter)
Kalchem International, Inc.DNDLC1/8/20071/9/2008

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