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Warning Letters 2010

Posted Jun 16 2010 9:14am
2010 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. []

June 2010
Product/Issue Company/Individual Division Released Posted

NDA 021539
ACETADOTE® (acetylcysteine) Injection

 Cumberland Pharmaceuticals, Inc. Division of Drug Marketing, Advertising and Communications 6/14/10 6/17/10

BLA # 125338
XIAFLEX™ (collagenase clostridium histolyticum) for injection, for intralesional use

 Auxilium Pharmaceuticals, Inc. Division of Drug Marketing, Advertising and Communications 6/10/10 6/17/10

NDA # 021476
Lunesta® (eszopiclone) Tablets

 Sepracor, Inc. Division of Drug Marketing, Advertising and Communications 6/9/10 6/17/10

marketing of unapproved new drugs

 Adamis Pharmaceuticals Office of Compliance 6/9/10 6/15/10

H1N1 Flu Virus-Related Products 

 Homeopathy for Health (elixirs) Office of Compliance 6/8/10 6/15/10

May 2010
Product/Issue Company/Individual Division Released Posted

NDA 20-637 GLIADEL®

 Eisai Corporation of North America Division of Drug Marketing, Advertising and Communications 5/27/10 6/17/10

H1N1 Flu Virus-Related Products

 Feel Good Natural Health Stores
 Office of Compliance 5/21/10 6/4/10

BLA # 125147
Vectibix® (panitumumab) Solution for Intravenous Infusion

 Amgen, Inc. Division of Drug Marketing, Advertising and Communications 5/13/10 5/24/10
April 2010
Product/Issue Company/Individual Division Released Posted

BLA # 103705
Rituxan® (Rituximab) Injection for Intravenous Use

 Genentech, Inc. Division of Drug Marketing, Advertising and Communications 4/29/10 5/5/10

NDA 022000
LIALDA®(mesalamine) Delayed Release Tablets

 Shire Development, Inc. Division of Drug Marketing, Advertising and Communications 4/27/10 5/5/10

NDA #020049
PENTASA® (mesalamine) Controlled-Release Capsules

 Shire Development, Inc. Division of Drug Marketing, Advertising and Communications 4/27/10 5/5/10

Institutional Review Board

 Ephraim McDowell Regional Medical Center Division of Scientific Investigations 4/26/10 4/30/10

Institutional Review Board

 Brookwood Medical Center Division of Scientific Investigations 4/22/10 4/30/10

NDA 021588
Gleevec® (imatinib mesylate)

 Novartis Oncology Division of Drug Marketing, Advertising and Communications 4/21/10 5/4/10

NDA 021775
ENTEREG® (alvimopan) Capsules

 Adolor Corporation Division of Drug Marketing, Advertising and Communications 4/21/10 4/23/10

NDA 021731
Eligard 45mg (leuprolide acetate for injectable suspension)

 Sanofi-Aventis U.S., Inc. Division of Drug Marketing, Advertising and Communications 4/20/10 4/23/10

NDA 22-055
Altabax® (retapamulin ointment), 1%

 GlaxoSmithKline Division of Drug Marketing, Advertising and Communications 4/19/10 4/30/10

BLA #125326
Arzerra™ (ofatumumab) Injection, for intravenous infusion

 GlaxoSmithKline   4/15/10 4/16/10

NDA # 022122
Voltaren® Gel (diclofenac sodium topical gel)

 Novartis Consumer Health, Inc. Division of Drug Marketing, Advertising and Communications 4/14/10 4/16/10

H1N1 Flu Virus-Related Products

 Super Body Care Office of Compliance 4/13/10 4/23/10

H1N1 Flu Virus Related Products

 Shreeji Homeo Clinic Office of Compliance 4/13/10 4/27/10

NDA #21-518
VESIcare® (solifenacin succinate) Tablets

 Astellas Pharma US, Inc. Division of Drug Marketing, Advertising and Communications 4/12/10 4/16/10

Unapproved/ Unauthorized Products Related to the H1N1 Flu Virus

 e-holistic health (Hannah Cooper) Office of Compliance 4/12/10 4/23/10

NDA #021135
Venofer® (iron sucrose injection, USP)

 Luitpold Pharmaceuticals, Inc. Division of Drug Marketing, Advertising and Communications 4/12/10 4/16/10

Sponsor Investigation

 Pfizer, Inc. Division of Scientific Investigations 4/9/10 4/23/10

NDA #010104
MEPHYTON® (PHYTONADIONE) Vitamin K1

 Aton Pharma, Inc. Division of Drug Marketing, Advertising and Communications 4/6/10 4/7/10

False/misleading claims related to LipoDissolve products

 Pure med spa Office of Compliance 4/6/10 4/7/10

NDA #s 20-628, 21-785 Invirase® (saquinavir mesylate) Capsules and Tablets

 Hoffman-La Roche Inc Division of Drug Marketing, Advertising and Communications 4/6/10 4/23/10

False/misleading claims related to LipoDissolve products

 All about you medispa Office of Compliance 4/5/10 4/7/10

False/misleading claims related to LipoDissolve products

 Idinhealth Office of Compliance 4/5/10 4/7/10

False/misleading claims related to LipoDissolve products

 Monarch medispa Office of Compliance 4/5/10 4/7/10

False/misleading claims related to LipoDissolve products

 Spa 35 Office of Compliance 4/5/10 4/7/10

False/misleading claims related to LipoDissolve products

 Medical Cosmetic Office of Compliance 4/5/10 4/7/10

Clinical Investigation

 Robert Deitz, M.D. Division of Scientific Investigations 4/1/10 4/23/10
March 2010
Product/Issue Company/Individual Division Released Posted

Inspection of pharmaceutical manufacturing facility

 Apotex Inc. Division of Manufacturing and Product Quality 3/29/10 4/23/10

Violations of Current Good Manufacturing Practice (CGMP) regulations

 Pierre Fabre Medicament Production Division of Manufacturing and Product Quality
 3/26/10 5/10/10

NDA # 021752
Truvada® (emtricitabine and tenofovir disoproxil fumarate) Tablets

 Gilead Sciences, Inc. Division of Drug Marketing, Advertising and Communications 3/26/10 4/7/10

BLA 103792
HERCEPTIN® (trastuzumab) Intravenous Infusion

 Genentech, Inc. Division of Drug Marketing, Advertising and Communications 3/26/10 4/23/10

BLA #125104
TYSABRI® (natalizumab) injection for intravenous use

 Biogen Idec, Inc. Division of Drug Marketing, Advertising and Communications 3/25/10 4/7/10

ANDA #80-911
Testopel® Pellets (testosterone), CIII

 Slate Pharmaceuticals, Inc. Division of Drug Marketing, Advertising and Communications 3/24/10 4/16/10

NDA #22-246
METOZOLV™ ODT (metoclopramide hydrochloride) orally disintegrating tablets

 Salix Pharmaceuticals, Inc. Division of Drug Marketing, Advertising and Communications 3/19/10 4/7/10

Clinical Investigator

 Sant P. Chawla, M.D. Division of Scientific Investigations 3/17/10 4/7/10

Nitroglycerin Tablets, 0.3 mg, 0.4 mg, and 0.6 mg

 Glenmark Generics, Inc. Office of Compliance 3/16/10 3/16/10

Nitroglycerin Tablets, 0.3 mg, 0.4 mg, and 0.6 mg

 Konec, Inc. Office of Compliance 3/16/10 3/16/10

NDA #21-664
XIBROM (bromfenac ophthalmic solution) 0.09%

 ISTA Pharmaceuticals, Inc. Division of Drug Marketing,
Advertising, and Communications		 3/10/10 3/16/10

Clinical Investigator

 Henry Lin, M.D. Division of Scientific Investigations 3/8/10 3/16/10

Morphine Sulfate Concentrate Oral Solution 20 mg/ml

 Paddock Laboratories, Inc. Office of Compliance 3/1/10 3/15/10
February 2010
Product/Issue Company/Individual Division Released Posted

Clinical Investigator

 Timothy Summers, M.D. Division of Scientific Investigations 2/24/10 3/15/10

NDA #20-616
Kadian® (morphine extended-release) Capsules, CII

 Actavis US
 Division of Drug Marketing,
Advertising, and Communications		 2/18/10 3/16/10

NDA 22-212
Durezol™ (difluprednate ophthalmic emulsion) 0.05%

 Sirion Therapeutics, Inc.
 Division of Drug Marketing,
Advertising, and Communications		 2/18/10 3/16/10

Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus

 natures gift Office of Compliance 2/16/10 3/16/10

Clinical Investigator

 Sohail Punjwani, M.D.
 Division of Scientific Investigations 2/4/10 3/15/10

NDA # 20-690
Aricept (donepezil hydrochloride) Tablets

 Eisai Medical Research Inc. Division of Drug Marketing,
Advertising, and Communications		 2/3/10 2/18/10
January 2010
Product/Issue Company/Individual Division Released Posted

NDA #21-782
RozeremTM (ramelteon) Tablets

 Takeda Pharmaceuticals North America, Inc. Division of Drug Marketing,
Advertising, and Communications		 1/28/10 3/19/10

manufacture of APIs

 XiAn Libang Pharmaceutical Co., Ltd.
 Division of Manufacturing and Product Quality 1/28/10 3/19/10

NDA #22-332
AdcircaTM (tadalafil) Tablets

 Lilly Corporate Center Division of Drug Marketing,
Advertising, and Communications		 1/27/10 2/2/10

NDA #20-114
ASTELIN®(azelastine hydrochloride) Nasal Spray

 Meda Pharmaceuticals, Inc. Division of Drug Marketing,
Advertising, and Communications		 1/26/10 2/2/10

NDA # 50-756
BenzaClin® (clindamycin 1% - benzoyl peroxide 5%) gel

 sanofi-aventis U.S. LLC Division of Drug Marketing,
Advertising, and Communications		 1/22/10 2/2/10

NDA #22-159
OraVerse (phentolamine mesylate) Injection

 Novalar Pharmaceuticals, Inc. Division of Drug Marketing,
Advertising, and Communications		 1/22/10 2/2/10

BLA #125274 Dysport (abobotulinumtoxinA) for Injection

 Baumann Cosmetic and Research Institute Division of Drug Marketing,
Advertising, and Communications		 1/11/10 1/22/10

NDA #18-735, 20-327 Isovue® (iopamidol injection)

 Bracco Diagnostics Inc. Division of Drug Marketing,
Advertising, and Communications		 1/7/10 1/22/10

NDA #20-351, 20-808 Visipaque™ (iodixanol) Injection

 GE Healthcare Division of Drug Marketing,
Advertising, and Communications		 1/7/10 1/22/10

NDA #22-148
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use

 Eli Lilly and Company Division of Drug Marketing,
Advertising, and Communications		 1/7/10 1/12/10

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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