Drugs

Warning Letters 2002

2002 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 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Retin-A Micro (tretinoin gel) microsphereJohnson & JohnsonDivision of Drug Marketing, Advertising, and Communications12/3/200212/10/2002
Taxotere (docetaxel) for injectionAventis PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications12/15/20021/31/2003
Transderm Scop (scopolamine) Transdermal Therapeutic SystemNovartisDivision of Drug Marketing, Advertising, and Communications12/3/200211/14/2002
November 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Actos (pioglitazone hydrochloride) tabletsTakeda Pharmaceuticals North America, Inc.Division of Drug Marketing, Advertising, and Communications11/7/200211/14/2002
Methotrexate, Leucovorin, and Amicar - Warning LetterXanodyne Pharmacal, Inc.Division of Drug Marketing, Advertising, and Communications11/14/200211/26/2002
Plan B (levonorgestrel) tabletsWomen's Capital CorporationDivision of Drug Marketing, Advertising, and Communications11/19/200211/26/2002
Reminyl (galantamine HBr)Janssen Research Foundation.Division of Drug Marketing, Advertising, and Communications11/20/200211/26/2002
Site Inspection (Warning Letter)Mayne Pharma Pty., Ltd.DMPQ11/21/200212/18/2002
Suprax (cefixime) OralWyeth-AyerstDivision of Drug Marketing, Advertising, and Communications11/5/200211/14/2002
October 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Guaifenesin: single product Warning Letters (45 total)Multiple CompaniesOffice of Compliance10/11/200211/8/2002
Guaifenesin: mulitple products Warning Letters (26 total)Multiple CompaniesOffice of Compliance10/11/200211/8/2002
Mobic (meloxicam) tabletsBoehringer Ingelheim PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications10/24/200211/27/2002
Tracleer (bosentan) tabletsActelion Pharmaceuticals US, Inc.Division of Drug Marketing, Advertising, and Communications10/30/200211/14/2002
September 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
CelexaForest LaboratoriesDivision of Drug Marketing, Advertising, and Communications9/13/200210/3/2002
Geodon (ziprasidone HCL)Pfizer, Inc.Division of Drug Marketing, Advertising, and Communications9/3/20029/19/2002
August 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Cedax (ceftibuten)Biovail PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications8/22/20029/19/2002
Lipitor (Atorvastatin calcium) tabletsPfizer, Inc.Division of Drug Marketing, Advertising, and Communications8/12/20029/4/2002
Prevacid (lansoprazole) delayed release capsulesTAP Pharmaceutical Products, Inc.Division of Drug Marketing, Advertising, and Communications8/2/20029/4/2002
Zanaflex (Tizanidine HCL) tabletsElan PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications8/5/20029/4/2002
July 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Accutane (isotretinoin) capsules Hoffman-LaRoche Inc.Division of Drug Marketing, Advertising, and Communications7/25/20029/4/2002
Neurontin (gabapentin)PfizerDivision of Drug Marketing, Advertising, and Communications7/1/20027/18/2002
June 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Adipokinetix - Warning LetterBetter-BodiesOffice of Compliance6/12/20026/14/2002
Adrenalin - Warning LetterMuscle Lane, Inc.Office of Compliance6/12/20026/14/2002
Clinical Investigator - Warning LetterLeonard J. Caputo, MDDSI6/11/20026/18/2002
Clinical Investigator - Warning LetterDavid R. Hassman, MDDSI6/5/20026/18/2002
Hollywood Cuts - Warning LetterScientifically Advanced NutritionOffice of Compliance6/12/20026/14/2002
Overdrive - Warning LetterDiabetes TeaOffice of Compliance6/12/20026/14/2002
Phenylkinetics, Libido Magic - Warning Letter21st Century Sports Nutrionals, Inc.Office of Compliance6/12/20026/14/2002
Lipodryl II - Warning LetterThermoLife InternationalOffice of Compliance6/12/20026/14/2002
Ephedra or Ma Huang - Warning LetterHerbtechOffice of Compliance6/12/20026/14/2002
May 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Imitrex (sumatriptan succinate) tablets GlaxoSmithKlineDivision of Drug Marketing, Advertising, and Communications5/13/20025/21/2002
Tamiflu (oseltamivir phosphate) capsulesHoffman-La RocheDivision of Drug Marketing, Advertising, and Communications5/16/20026/7/2002
April 2002
Product/IssueCompany/IndividualDivisionReleasedPosted
Nicotine Lollipops - Warning LetterAshland DrugOffice of Compliance4/9/20025/21/2002
Nicotine Lollipops - Warning LetterThe Compounding PharmacyOffice of Compliance4/9/20025/21/2002
Nicotine Lollipops - Warning LetterBird's Hill PharmacyOffice of Compliance4/9/20025/21/2002
Zyrtec (cetirizine HCl) TabletsPfizer Inc.Division of Drug Marketing, Advertising, and Communications4/30/20025/16/2002
March 2002
Product/IssueCompany/IndividualDivisionReleasedPosted

Viread (tenofovir disoproxil fumarate) tablets

 

 

Gilead Sciences, Inc.Division of Drug Marketing, Advertising, and Communications3/14/20023/22/2002
January 2002
Product/IssueCompany/IndividualDivisionReleasedPosted

IC351

 

 

 

Lilly ICOS LLCDivision of Marketing, Advertising, and Communications1/3/20021/14/2002

Provigil (modafinil) tablets

 

Cephalon Inc.    Division of Drug Marketing, Advertising, and Communications   1/3/2009    1/14/2002     

Viread (tenofovir disoproxil fumarate) tablets

 

 

Gilead Sciences, Inc.Division of Drug Marketing, Advertising, and Communications3/14/20023/22/2002

Xalatan (latanoprost ophthalmic solution)

 

Pharmacia & UpjohnDivision of Drug Marketing, Advertising, and Communications1/16/20022/20/2002
Xeloda (capecitabine) tabletsHoffman-La RocheDivision of Drug Marketing, Advertising, and Communications1/9/20022/20/2002
Zanaflex (tizanidine HCl) tabletsElan PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications1/16/20022/20/2002

 

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

Instructions for how to submit an FOI request can be found on the FDA FOI Page.

The letters are arranged in chronological order by month.  Click on the product name to view the letters in Adobe Acrobat (PDF) format.

 

Page Last Updated: 03/28/2016
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