Drugs

Warning Letters 2008

2008 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 2008
Product/Issue Company/Individual Division Released Posted

HUMIRA (adalimumab) Injection

Abbott Laboratories Division of Drug Marketing, Advertising, and Communications 12/16/2008 12/23/2008

Seroquel (quetiapine fumarate)

AstraZeneca Division of Drug Marketing, Advertising, and Communications 12/1/2008 12/4/2008

Xodol (hydrocodone bitartrate and acetaminophen) tablets

Victory Pharma, Inc. Division of Drug Marketing, Advertising, and Communications 12/12/2008 12/15/2008
November 2008
Product/Issue Company/Individual Division Released Posted

Cedax (ceftibuten capsules and ceftibuten for oral suspension) (Warning Letter)

Shionogi USA, Inc. Division of Drug Marketing, Advertising, and Communications 11/14/2008 11/20/2008

Tracleer (bosentan) Tablets

Actelion Pharmaceuticals US, Inc. Division of Drug Marketing, Advertising, and Communications 11/24/2008 11/25/2008

Voraxaze

Protherics, Inc. Division of Drug Marketing, Advertising, and Communications 11/14/2008 11/20/2008
October 2008
Product/Issue Company/Individual Division Released Posted
Bayer Aspirin with Hearth Advantage (Warning Letter) Bayer HealthCare L.L.C. Division of New Drugs & Labeling Compliance 10/27/2008 10/28/2008
Bayer Women's Low Dose Aspirin + Calcium (Warning Letter) Bayer HealthCare L.L.C. Division of New Drugs & Labeling Compliance 10/27/2008 10/28/2008
Clinical Investigator (Warning Letter) Richard Holub, M.D. Division of Scientific Investigations. 10/1/2008 10/24/2008

Sensipar (cinacalcet) tablets

Amgen Division of Drug Marketing, Advertising, and Communications 10/27/2008 10/29/2008
SINUS SCIENCE Aerosol Medication Delivery System (Warning Letter) Aerosol Science Laboratories Inc. Division of New Drugs & Labeling Compliance 10/29/2008 11/14/2008

YAZ (drospirenone and ethinyl estradiol) Tablets (Warning Letter)

Bayer HealthCare Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications 10/3/2008 10/7/2008
September 2008
Product/Issue Company/Individual Division Released Posted

Adderall XR Capsules (Warning Letter)

Shire Development Division of Drug Marketing, Advertising, and Communications 9/25/2008 9/26/2008
Clinical Investigator (Warning Letter) Gregory Gardziola Division of Scientific Investigations 9/3/2008 10/24/2008

Concerta (methylphenidate HCl)

Johnson & Johnson Division of Drug Marketing, Advertising, and Communications 9/25/2008 9/26/2008

Focalin XR (dexmethylphenidate)

Novartis Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 9/25/2008 9/26/2008

Methylin (methylphenidate HCl)

Mallinckrodt Inc. Division of Drug Marketing, Advertising, and Communications 9/25/2008 9/26/2008

Mirapex (pramipexole dihydrochloride) (Warning Letter)

Boehringer-Ingelheim Division of Drug Marketing, Advertising, and Communications 9/29/2008 10/2/2008

Strattera (atomoxetine HCl) (Warning Letter)

Eli Lilly & Company Division of Drug Marketing, Advertising, and Communications 9/25/2008 9/26/2008
Ranbaxy Laboratories Limited Division of Manufacturing and Product Quality 9/16/2008 9/16/2008
August 2008
Product/Issue Company/Individual Division Released Posted

Bystolic (nebivolol) Tablets (Warning Letter)

Forest Laboratories, Inc. Division of Drug Marketing, Advertising, and Communications 8/28/2008 9/8/2008

Diovan (valsartan) Tablets

Novartis Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 8/28/2008 9/26/2008
Institutional Review Board (Warning Letter) Hospital Municipal de San Juan IRB Division of Scientific Investigations 8/15/2008 8/20/2008
June 2008
Product/Issue Company/Individual Division Released Posted
Clinical Investigator (Warning Letter) Nagarjuna R. Ponugoti, M.D. Division of Scientific Investigations 6/6/2008 7/9/2008
Sponsor-Applicant-Monitor-CRO (Warning Letter) Travanti Pharma, Inc. Division of Scientific Investigations 6/30/2008 7/2/2008
May 2008
Product/Issue Company/Individual Division Released Posted
Clinical Investigator (Warning Letter) Arturo Corces, M.D. Division of Scientific Investigations 5/28/2008 7/9/2008
Sponsor-Investigator (Warning Letter) Willa A. Hsueh, M.D. Division of Scientific Investigations 5/30/2008 7/9/2008
Sponsor/Investigator (Warning Letter) Edward Mostel, M.D.. Division of Scientific Investigations 5/16/2008 7/9/2008

Fosrenol

Shire Development, Inc. Division of Drug Marketing, Advertising, and Communications 5/1/2008 5/8/2008

Trileptal (Warning Letter)

Novartis Pharmaceuticals Corporation Division of Drug Marketing, Advertising, and Communications 5/1/2008 5/8/2008
April 2008
Product/Issue Company/Individual Division Released Posted
Inspection (Warning Letter) Changzhou SPL Company, Ltd. Division of Manufacturing and Product Quality 4/21/2008 4/21/2008

Peridex (Warning Letter)

Zila Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications 4/18/2008 4/22/2008
Viagra (Warning Letter) Pfizer, Inc. Division of Drug Marketing, Advertising, and Communications 4/16/2008 4/21/2008
March 2008
Product/Issue Company/Individual Division Released Posted

Avinza (Warning Letter)

King Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications 3/24/2008 3/26/2008
Clinical Investigator (Warning Letter) Saroj Brar, M.D. Division of Scientific Investigations 3/20/2008 4/22/2008
Clinical Investigator (Warning Letter) Ashok Shah, M.D. Division of Scientific Investigations 3/19/2008 4/22/2008
Clinical Investigator (Warning Letter) Frank Whittier, M.D. Division of Scientific Investigations 3/6/2008 4/22/2008
Institutional Review Board (Warning Letter) Coast Institutional Review Board Division or Scientific Investigations 3/11/2008 3/26/2008
February 2008
Product/Issue Company/Individual Division Released Posted
Clinical Investigator (Warning Letter) Kevin W. Klein, M.D. Division or Scientific Investigations 2/13/2008 2/28/2008
Clinical Investigator (Warning Letter) Nasim Golzar, MD Division of Scientific Investigations 2/13/2008 5/15/2008
Institutional Review Board (Warning Letter) West Jefferson Medical Center IRB Division of Scientific Investigations 2/25/2008 4/1/2008
January 2008
Product/Issue Company/Individual Division Released Posted
Sponsor-Applicant-Monitor-Clinical Research Organization (Warning Letter) Replidyne, Inc. Division or Scientific Investigations 1/18/2008 2/15/2008
Inspection (Warning Letter) Tomita Pharmaceutical Co., Ltd Division of Manufacturing and Product Quality 1/14/2008 1/23/2008

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

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.  

 

 

Page Last Updated: 03/28/2016
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