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Warning Letters 2009


2009 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...]

 

June 2009
Product/Issue Company/Individual Division Released Posted

Clinical Investigation

 Mark Gordon, M.D. Division of Scientific Investigations 6/26/2009 7/7/09

Clinical Investigation

 Noli R Zosa, M.D. Division of Scientific Investigations 6/16/2009 7/7/09

Velcade (bortezomib) for injection

 Millennium Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications 6/18/2009 6/23/09

 

May 2009
Product/Issue Company/Individual Division Released Posted

Alinia (nitazoxanide) Tablets and (nitazoxanide) for Oral Suspension

 Romark Laboratories, L.C. Division of Drug Marketing, Advertising, and Communications 5/26/2009 6/22/09

PerioChip (chlorhexidine gluconate) (Warning Letter)

 Dexcel Pharma Technologies Ltd. Division of Drug Marketing, Advertising, and Communications 5/14/2009 5/19/2009

Spectracef (cefditoren pivoxil) Tablets (Warning Letter)

 Cornerstone Therapeutics, Inc. Division of Drug Marketing, Advertising, and Communications 5/4/2009 5/19/2009
ULTRAM ER (tramadol HCl) (Warning Letter) Johnson & Johnson Division of Drug Marketing, Advertising, and Communications 5/12/2009 5/19/2009
Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Amrita Aromatherapy, Inc Office of Compliance 5/28/2009 6/22/2009
Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Nozin LLC Office of Compliance 5/22/2009 6/22/2009

 

April 2009
Product/Issue Company/Individual Division Released Posted
Taxotere (docetaxel) sanofi-aventis Division of Drug Marketing, Advertising, and Communications 4/16/2009 5/13/2009
Clinical Investigation (Warning Letter) Coast IRB Division of Scientific Investigations 4/14/2009 4/14/2009
Site Inspection (Warning Letter) Qingdao Jiulong Biopharmaceuticals Co. Ltd. Division of Manufacturing and Product Quality 4/14/2009 4/16/2009

BLA 125104 Tysabri (natalizumab) injection for intravenous use

 

 Biogen Idec Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 20-839 Plavix (clopidogrel bisulfate) Tablets

 Sanofi Aventis, U.S. Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-400 LEVITRA (vardenafil HCl) Tablets; NDA 21-676, 21-873, 22-045 YAZ (drospirenone and ethinyl estradiol) Tablets; NDA 21-225 Mirena (levonorgestrel-releasing intrauterine system)

 Bayer Healthcare Pharmaceuticals, Inc.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-071 Avandia (rosiglitazone maleate) Tablets; NDA 21-410 Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets; NDA 21-700 Avandaryl (rosiglitazone maleate and glimepiride) Tablets; NDA 21-319 Avodart (dutasteride) Soft Gelatin Tablets; NDA 22-012 Coreg CR (carvedilol phosphate) Extended-release Capsules; NDA 22-059 Tykerb (lapatinib) Tablets

 GlaxoSmithKline Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-742 BYSTOLIC (nebivolol) Tablets; NDA 21-431 CAMPRAL (acamprosate calcium) Delayed-Release Tablets; NDA 21-323, 21-365, 21-440 Lexapro (escitalopram) Tablets/ Oral Solution; NDA 21-487, 21-627 Namenda (memantine) Tablets/Oral Solution

 Forest Laboratories, Inc. Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-947 FENTORA (fentanyl buccal tablet); NDA #22-249 TREANDA (bendamustine hydrochloride) for Injection, for intravenous infusion

 Cephalon, Inc. Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-976 PREZISTA (darunavir) Tablet

 Johnson & Johnson Pharmaceutical Services
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 20-753 AROMASIN (exemestane) tablets; NDA 21-540 CADUET (amlodipine besylate/atorvastatin calcium) Tablets; NDA 21-928 CHANTIX® (varenicline) Tablets; NDA 21-228 Detrol LA (tolterodine tartrate) extended release capsules; NDA 21-446, 21-723, 21-724 LYRICA (pregabalin) Capsules; NDA 20-998, 21-156 CELEBREX (celecoxib) capsules

 Pfizer, Inc.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 20-726 Femara (letrozole tablets); NDA 21-283 Diovan (valsartan) Tablets; NDA 21-990 Exforge (amlodipine and valsartan) Tablets; NDA 21-882 EXJADE (deferasirox) Tablets for Oral Suspension; NDA 21-588 GLEEVEC (imatinib mesylate) Tablets for Oral Use

 Novartis Pharmaceuticals Corp.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

BLA 125085 Avastin (Bevacizumab); BLA 125156 LUCENTIS (ranibizumab injection); BLA 103705, 103737 RITUXAN (rituximab); BLA 103976 Xolair (Omalizumab) For Subcutaneous Use; BLA 103792 HERCEPTIN (trastuzumab); BLA 103532 Pulmozyme (dornase alfa) Inhalation Solution

 Genentech, Inc.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-395 Spiriva HandiHaler (tiotropium bromide inhalation powder); NDA 20-579 Flomax (tamsulosin hydrochloride) Capsules; NDA 20-667 Mirapex (pramipexole dihydrochloride) Tablets

 Boehringer Ingelheim Pharmaceuticals, Inc.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-995 JANUVIA (sitagliptin) Tablets; NDA 20-788 PROPECIA (finasteride) Tablets; NDA 20-829, 20-830, 21-409 SINGULAIR (montelukast sodium) granule;
tablet, chewable; tablet, film coated; NDA 21-549 EMEND (aprepitant) Capsules

 Merck & Co., Inc.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-455, 21-858 BONIVA (ibandronate sodium) Tablets; BLA 103964 PEGASYS (peginterferon alfa-2a) for Injection; NDA 20-896 XELODA (capecitabine) Tablets

 Hoffman-LaRoche, Inc.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009

NDA 21-427, 21-733, 22-148 Cymbalta (duloxetine hydrochloride) Delayed-
Release Capsules for Oral Use; NDA 20-815, 22-042 EVISTA (raloxifene hydrochloride) Tablets for Oral Use; NDA 20-509 Gemzar (gemcitabine HCl) for Injection

 

 

 Eli Lilly and Co.
 Division of Drug Marketing, Advertising, and Communications 4/2/2009 4/3/2009
March 2009
Product/Issue Company/Individual Division Released Posted

Clinical Investigation

(Warning Letter)

 Ronald Bukowski, M.D. Division of Scientific Investigations 3/30/2009 4/21/2009
Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml Glenmark Generics Inc.
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Hydromorphone HCI Tablets, 2mg and 4mg Lannett Company, Inc.
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Concentrate, 20 mg/ml Lehigh Valley Technologies Inc.
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Morphine Sulfate Concentrate Oral Solution 20mg/ml Mallinckrodt Inc. Pharmaceuticals Group
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg Xanodyne Pharmaceuticals Inc.
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Morphine Sulfate Immediate Release Tablets, 30 mg; Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg		 Physicians Total Care, Inc.
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg Roxane Laboratories, Inc.  
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg Boehringer Ingelheim Roxane Inc. 
PDF version		 Office of Compliance 3/30/2009 3/31/2009
Morphine Sulfate Solution Immediate Release 20mg/ml
 Cody Laboratories, Inc. 
PDF version		 Office of Compliance 3/30/2009 3/31/2009

Treximet (sumatriptan and naproxen sodium) Tablets

 GlaxoSmithKline Division of Drug Marketing, Advertising, and Communications 3/9/2009 4/7/2009

Clinical Investigation (Warning Letter)

 

 

 Charles J. Cote, M.D. Division of Scientific Investigations 3/2/2009 3/3/2009

Clinical Investigation (Warning Letter)

 

 

 Virendra Desai, M.D. Division of Scientific Investigations 3/2/2009 3/5/2009

Clinical Investigation (Warning Letter)

 

 

 Manuel J. Quinones, M.D. Division of Scientific Investigations 3/3/2009 3/5/2009
February 2009
Product/Issue Company/Individual Division Released Posted

Avodart (dutasteride) Soft Gelatin Capsules

 

 

 GlaxoSmithKline Division of Drug Marketing, Advertising, and Communications
 2/18/2009 2/26/2009

Inspection of Pharmaceutical Manufacturing Facility (Warning Letter)

 

 

 Barrie Levitt, M. D. Division of Manufacturing & Product Quality
 2/5/2009 2/5/2009
Letairis (ambrisentan) Gilead Sciences, Inc. Division of Drug Marketing, Advertising, and Communications 2/27/2009 3/5/2009

January 2009
Product/Issue Company/Individual Division Released Posted

Clinical Investigation (Warning Letter)

 

 

 

 Nicola Spirtos, M.D Division of Scientific Investigations
 1/3/2009 1/22/2009

Depakote (divalproex sodium)

 

 Abbott Laboratories     Division of Drug Marketing, Advertising, and Communications   
 1/22/2009     1/29/2009     

Sanctura (trospium chloride)

 

 

 Indevus Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications 1/27/2009 1/29/2009

 

 

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. 

 

    

    
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