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Warning Letters 2010

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.  [more...]

 

December 2010

 Product/IssueCompany/IndividualDivisionReleasedPosted

Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs

Klinge Chemicals UnlimitedDivision of Manufacturing and Product Quality12/21/101/4/11

Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs

Synbiotics Limited c/o Ambalal Sarabhai EnterprisesDivision of Manufacturing and Product Quality12/16/1012/22/10

Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs

Macco Organiques, Inc.Division of Manufacturing and Product Quality
 		12/10/1012/17/10

Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs
 

Yuki Gosei Kogyo Co., Ltd.Division of Manufacturing and Product Quality12/9/1012/23/10

NDA 19452 Derma-Smoothe/FS (flucinolone acetonide) Topical Oil, 0.01% (Body Oil)

Hill Dermaceuticals, Inc.

Division of Drug Marketing and Communications12/3/1012/13/10

November 2010

 Product/IssueCompany/IndividualDivisionReleasedPosted

NDA 22204 Gelnique (oxybutynin chloride) 10% gel

Watson Pharmaceuticals, Inc.

Division of Drug Marketing and Communications11/30/1012/9/10

Website contains false or misleading claims related to your Lipodissolve products

Vanderveer CenterDivision of New Drugs and Labeling Compliance
 		11/18/1012/7/10

NDA 21275 Lumigan (bimatoprost ophthalmic solution) 0.03%

Allergan Inc.Division of Drug Marketing and Communications11/18/1012/6/10

NDA 21897 VIVITROL (naltrexone for extended-release injectable suspension)

Alkermes Inc.Division of Drug Marketing and Communications 11/4/10 11/15/10

 INCRELEX® (mecasermin [rDNA origin] injection)
 

 Tercica Inc.
 		 Division of Drug Marketing and Communications 11/3/1011/5/10

Violations of Current Good Manufacturing Practice (CGMP) regulations

Claris Lifesciences Limited
 		Division of Manufacturing and Product Quality
 		 11/1/10 11/15/10

October 2010

Product/IssueCompany/IndividualDivisionReleasedPosted

Violations of Current Good Manufacturing Practice (CGMP) regulations

CP Pharmaceuticals, LtdDivision of Manufacturing and Product Quality
 		10/29/1011/15/10

Clinical Investigator

Howard L. Lippton, MDDivision of Scientific Investigations10/20/1010/25/10

Clinical Investigator

David F. Scott, MDDivision of Scientific Investigations10/20/1010/27/10

NDA 020410, 022180
GastroMARK® (ferumoxsil, oral suspension)
Feraheme™ (ferumoxytol) Injection For Intravenous (IV) use
 

AMAG Pharmaceuticals, Inc.
 		Division of Drug Marketing and Communications10/18/1010/25/10

active pharmaceutical ingredient (API) manufacturing facility

Yunnan Hande Bio-Tech Co., Ltd.
 		Division of Manufacturing and Product Quality
 		10/15/1010/25/10

NDA #021994

Travatan Z

Alcon Research Ltd.Division of Drug Marketing and Communications10/12/1010/21/10

Internet Marketing of Unapproved and Misbranded Drugs

Rx-promotionDivision of New Drugs and Labeling 
Compliance
 		10/8/1010/12/10

September 2010

Product/IssueCompany/IndividualDivisionReleasedPosted

violations of Current Good Manufacturing Practice (CGMP) regulations

Qualiphar n.v.
 		Division of Manufacturing and Product Quality
 		9/30/1010/15/10

violations of Current Good Manufacturing Practice (CGMP) regulations

Choksi Laboratories, Ltd.           
 		Division of Manufacturing and Product Quality
 		9/30/1010/18/10

Clinical Investigator

Thomas O'Barr, Jr, M.D.Division of Scientific Investigations9/30/109/30/10

deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs

Kyowa Hakko Kogyo Co., Ltd.
 		Division of Manufacturing and Product Quality
 		9/29/1010/18/10

Clinical Investigator

Lamar L. Snow, M.D.Division of Scientific Investigations9/29/109/29/10

Clinical Investigator

Joel Picus, M.D.  Division of Scientific Investigations9/20/109/20/10

Institutional Review Board

Bay Regional Medical CenterDivision of Scientific Investigations9/9/109/15/10
RUYAN brand of products

Ruyan America, Inc.

 

Division of New Drugs and Labeling Compliance9/8/109/8/10

products marketed under the “Gamucci” name

Gamucci AmericaDivision of New Drugs and Labeling Compliance9/8/109/8/10

various brands of electronic cigarettes and cigars (e.g., “Gamucci,”“Smoking Everywhere,” and “Veppo”), and the components thereof (e.g., batteries and cartridges)

E-Cigarette Direct, LLCDivision of New Drugs and Labeling Compliance 9/8/109/8/10

E-Cig Technology electronic cigarettes, cigars, and USB cigarettes

E-Cig Technology Inc.Division of New Drugs and Labeling Compliance9/8/109/8/10

August 2010

Product/IssueCompany/IndividualDivisionReleasedPosted

NDA# 004782

Premarin

Wyeth Pharmaceuticals, Inc.Division of Drug Marketing and Communications8/27/109/8/10

NDA #022427

Acuvail™ (ketorolac tromethamine ophthalmic solution) 0.45%

Allergan, Inc.Division of Drug Marketing and Communications8/24/109/8/10
GLP for non-clinical laboratory studies

SNBL USA, Ltd.

 

Division of Scientific Investigations

8/9/108/24/10

July 2010

Product/IssueCompany/IndividualDivisionReleasedPosted

NDA 21990

Exforge (amlodipine and valsartan) Tablets

Novartis Pharmaceuticals Corporation

 

Division of Drug Marketing, Advertising and Communications		7/30/108/4/10

NDA 022068

Tasigna (nilotinib) Capsules

Novartis Pharmaceuticals Corporation

Division of Drug Marketing, Advertising and Communications

7/29/108/4/10

 

NDA 22047 

SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets

AstraZeneca LPDivision of Drug Marketing, Advertising and Communications7/29/108/4/10

TIGER BALM® Pain Relieving PATCH (Tiger Balm)

Haw Par Healthcare Limited
 		Division of Manufacturing and Product Quality
 		7/20/108/9/10

NDA 20451 & 21525  Photofrin® (porfimer sodium) for injection
 

Axcan Pharma, Inc.Division of Drug Marketing, Advertising and Communications7/13/107/13/10

NDA #022033
Luvox CR® (fluvoxamine maleate) Extended-Release Capsules

Jazz PharmaceuticalsDivision of Drug Marketing, Advertising and Communications7/6/107/6/10

 

June 2010

Product/IssueCompany/IndividualDivisionReleasedPosted

NDA 22052 Zyflo CR (zileuton) extended-release tablets

Cornerstone Therapeutics, Inc.Division of Drug Marketing, Advertising and Communications6/22/107/1/10

NDA

 #022037
Intuniv™ (guanfacine) extended-release tablets

Shire Development, Inc.Division of Drug Marketing, Advertising and Communications6/22/106/30/10

NDA 021539
ACETADOTE® (acetylcysteine) Injection

Cumberland Pharmaceuticals, Inc.Division of Drug Marketing, Advertising and Communications6/14/106/17/10

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

Auxilium Pharmaceuticals, Inc.Division of Drug Marketing, Advertising and Communications6/10/106/17/10

NDA # 021476
Lunesta® (eszopiclone) Tablets

Sepracor, Inc.Division of Drug Marketing, Advertising and Communications6/9/106/17/10

marketing of unapproved new drugs

Adamis PharmaceuticalsOffice of Compliance6/9/106/15/10

H1N1 Flu Virus-Related Products 

Homeopathy for Health (elixirs)Office of Compliance6/8/106/15/10

May 2010
Product/IssueCompany/IndividualDivisionReleasedPosted

NDA 20-637 GLIADEL®

Eisai Corporation of North AmericaDivision of Drug Marketing, Advertising and Communications5/27/106/17/10

H1N1 Flu Virus

Zone of Natural RemediesOffice of Compliance5/21/1011/19/10

H1N1 Flu Virus-Related Products

Feel Good Natural Health Stores
 		Office of Compliance5/21/106/4/10

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

Amgen, Inc.Division of Drug Marketing, Advertising and Communications5/13/105/24/10

deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs

Jilin Shulan Synthetic Pharmaceutical Co., Ltd.
 		Division of Manufacturing and Product Quality
 		5/13/1010/19/10

Pharmaceutical manufacturing facility Inspection

Laboratorios L.O., Oftalmi, C.A.
 		Division of Manufacturing and Product Quality5/12/109/8/10

 

April 2010
Product/IssueCompany/IndividualDivisionReleasedPosted

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

Genentech, Inc.Division of Drug Marketing, Advertising and Communications4/29/105/5/10

NDA 022000
LIALDA®(mesalamine) Delayed Release Tablets

Shire Development, Inc.Division of Drug Marketing, Advertising and Communications4/27/105/5/10

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

Shire Development, Inc.Division of Drug Marketing, Advertising and Communications4/27/105/5/10

Institutional Review Board

Ephraim McDowell Regional Medical CenterDivision of Scientific Investigations4/26/104/30/10

Institutional Review Board

Brookwood Medical CenterDivision of Scientific Investigations4/22/104/30/10

NDA 021588
Gleevec® (imatinib mesylate)

Novartis OncologyDivision of Drug Marketing, Advertising and Communications4/21/105/4/10

NDA 021775
ENTEREG® (alvimopan) Capsules

Adolor CorporationDivision of Drug Marketing, Advertising and Communications4/21/104/23/10

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

Sanofi-Aventis U.S., Inc.Division of Drug Marketing, Advertising and Communications4/20/104/23/10

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

GlaxoSmithKlineDivision of Drug Marketing, Advertising and Communications4/19/104/30/10

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

GlaxoSmithKline 4/15/104/16/10

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

Novartis Consumer Health, Inc.Division of Drug Marketing, Advertising and Communications4/14/104/16/10

H1N1 Flu Virus-Related Products

Super Body CareOffice of Compliance4/13/104/23/10

H1N1 Flu Virus Related Products

Shreeji Homeo ClinicOffice of Compliance4/13/104/27/10

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

Astellas Pharma US, Inc.Division of Drug Marketing, Advertising and Communications4/12/104/16/10

Unapproved/ Unauthorized Products Related to the H1N1 Flu Virus

e-holistic health (Hannah Cooper)Office of Compliance4/12/104/23/10

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

Luitpold Pharmaceuticals, Inc.Division of Drug Marketing, Advertising and Communications4/12/104/16/10

Sponsor-Applicant-Monitor-Clinical Research Organization

Pfizer, Inc.Division of Scientific Investigations4/9/104/23/10

NDA #010104
MEPHYTON® (PHYTONADIONE) Vitamin K1

Aton Pharma, Inc.Division of Drug Marketing, Advertising and Communications4/6/104/7/10

False/misleading claims related to LipoDissolve products

Pure med spaOffice of Compliance4/6/104/7/10

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

Hoffman-La Roche IncDivision of Drug Marketing, Advertising and Communications4/6/104/23/10

False/misleading claims related to LipoDissolve products

All about you medispaOffice of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

IdinhealthOffice of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

Monarch medispaOffice of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

Spa 35Office of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

Medical CosmeticOffice of Compliance4/5/104/7/10

Clinical Investigator

Robert Deitz, M.D.Division of Scientific Investigations4/1/104/23/10
March 2010
Product/IssueCompany/IndividualDivisionReleasedPosted

Inspection of pharmaceutical manufacturing facility

Apotex Inc.Division of Manufacturing and Product Quality3/29/104/23/10

Violations of Current Good Manufacturing Practice (CGMP) regulations

Pierre Fabre Medicament ProductionDivision of Manufacturing and Product Quality
 		3/26/105/10/10

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

Gilead Sciences, Inc.Division of Drug Marketing, Advertising and Communications3/26/104/7/10

BLA 103792
HERCEPTIN® (trastuzumab) Intravenous Infusion

Genentech, Inc.Division of Drug Marketing, Advertising and Communications3/26/104/23/10

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

Biogen Idec, Inc.Division of Drug Marketing, Advertising and Communications3/25/104/7/10

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

Slate Pharmaceuticals, Inc.Division of Drug Marketing, Advertising and Communications3/24/104/16/10

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

Salix Pharmaceuticals, Inc.Division of Drug Marketing, Advertising and Communications3/19/104/7/10

Clinical Investigator

Sant P. Chawla, M.D.Division of Scientific Investigations3/17/104/7/10

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

Glenmark Generics, Inc.Office of Compliance3/16/103/16/10

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

Konec, Inc.Office of Compliance3/16/103/16/10

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

ISTA Pharmaceuticals, Inc.Division of Drug Marketing,
Advertising, and Communications		3/10/103/16/10

Sponsor-Investigator

Henry Lin, M.D.Division of Scientific Investigations3/8/103/16/10

Morphine Sulfate Concentrate Oral Solution 20 mg/ml

Paddock Laboratories, Inc.Office of Compliance3/1/103/15/10
February 2010
Product/IssueCompany/IndividualDivisionReleasedPosted

Clinical Investigator

Timothy Summers, M.D.Division of Scientific Investigations2/24/103/15/10

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

Actavis US
 		Division of Drug Marketing,
Advertising, and Communications		2/18/103/16/10

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

Sirion Therapeutics, Inc.
 		Division of Drug Marketing,
Advertising, and Communications		2/18/103/16/10

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

natures giftOffice of Compliance2/16/103/16/10

Clinical Investigator

Sohail Punjwani, M.D.
 		Division of Scientific Investigations2/4/103/15/10

NDA # 20-690
Aricept (donepezil hydrochloride) Tablets

Eisai Medical Research Inc.Division of Drug Marketing,
Advertising, and Communications		2/3/102/18/10

 

January 2010
Product/IssueCompany/IndividualDivisionReleasedPosted

NDA #21-782
RozeremTM (ramelteon) Tablets

Takeda Pharmaceuticals North America, Inc.Division of Drug Marketing,
Advertising, and Communications		1/28/103/19/10

Clinical Investigator

Samya Nasr, MDDivision of Scientific Investigations1/28/101/28/10

manufacture of APIs

XiAn Libang Pharmaceutical Co., Ltd.
 		Division of Manufacturing and Product Quality1/28/103/19/10

NDA #22-332
AdcircaTM (tadalafil) Tablets

Lilly Corporate CenterDivision of Drug Marketing,
Advertising, and Communications		1/27/102/2/10

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

Meda Pharmaceuticals, Inc.Division of Drug Marketing,
Advertising, and Communications		1/26/102/2/10

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

sanofi-aventis U.S. LLCDivision of Drug Marketing,
Advertising, and Communications		1/22/102/2/10

NDA #22-159
OraVerse (phentolamine mesylate) Injection

Novalar Pharmaceuticals, Inc.Division of Drug Marketing,
Advertising, and Communications		1/22/102/2/10

Sponsor-Investigator

Kirk M. Maxey, MDDivision of Scientific Investigations1/19/101/19/10

BLA #125274 Dysport (abobotulinumtoxinA) for Injection

Baumann Cosmetic and Research InstituteDivision of Drug Marketing,
Advertising, and Communications		1/11/101/22/10

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

Bracco Diagnostics Inc.Division of Drug Marketing,
Advertising, and Communications		1/7/101/22/10

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

GE HealthcareDivision of Drug Marketing,
Advertising, and Communications		1/7/101/22/10

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

Eli Lilly and CompanyDivision of Drug Marketing,
Advertising, and Communications		1/7/101/12/10

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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