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U.S. Department of Health and Human Services

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Warning Letters 2011

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER 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. 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.

 

Office of Prescription Drug Promotion

 Company/IndividualProduct/IssueIssue Date

Celgene Corporation

NDA 021660 Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)12/23/11

Dr. Reddy's Laboratories, Inc.

ANDA 91316 Fondaparinux Sodium Solution for subcutaneous injection12/22/11

Mutual Pharmaceutical Company, Inc.

NDA 022352 Colcrys (colchicine, USP) tablets for Oral use12/20/11

Sunovion Pharmaceuticals, Inc.

NDA 200603 Latuda (lurasidone HCl) Tablets12/14/11

NeurogesX, Inc.

NDA 022395 Qutenza (capsaicin) 8% patch12/13/11

EUSA Pharma (USA), Inc.

BLA 103608 ProstaScint Kit (Capromab Pendetide)12/13/11

Lantheus Medical Imaging, Inc.

NDA 17771 Technelite (Technetium Tc 99m Generator)10/25/11

Otsuka Pharmaceutical Development and Commercialization, Inc.

NDA 020954 Busulfex (busulfan) Injection10/17/11

Alcon Research, Ltd.

NDA 021545 Pataday (olopatadine hydrochloride ophthalmic solution) 0.2%10/14/11

Pfizer, Inc.

NDA 021928 Chantix (varenicline) Tablets, NDA 021540 Caduet (amlodipine besylate/atorvastatin calcium) Tablets, NDA 019787 Norvasc (amlodipine besylate) Tablets8/31/11

Ortho-McNeil-Janssen Pharmaceuticals, Inc.

NDA 022304 Nucynta (tapentadol) immediate-release oral tablets C-II8/26/2011

 CEL-SCI Corporation

Multikine (Leukocyte Interleukin) Injection8/5/11

Aton Pharma, a Division of Valeant Pharmaceuticals North America LLC

NDA 010104 Mephyton (phytonadione) Vitamin K1 Tablets8/2/11

ISTA Pharmaceuticals

NDA 021664 Bromday (bromfenac ophthalmic solution) 0.09%7/13/11

AOI Pharmaceuticals, Inc./Keryx Biopharmaceuticals, Inc.

KRX-0401 (perifosine)6/30/11

Cephalon, Inc.

NDA 021248 Trisenox (arsenic trioxide) injection6/21/11

Nycomed US,  Inc.

NDA 021005 Solaraze (diclofenac sodium) Gel, 3%6/17/11

Dow Pharmaceutical Sciences, Inc.

NDA 050819 Acanya (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%6/16/11
Novartis Pharmaceuticals Corporation NDA 021802 Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules Cll5/31/11

Noven Pharmaceuticals, Inc.

NDA 021299 Pexeva (paroxetine mesylate) Tablets5/24/11

Shire Pharmaceuticals, Inc.

NDA 021977 Vyvanse (lisdexamfetamine dimesylate) Capsules, CII5/6/11

Warner Chilcott (US, LLC

NDA 022560 Atelvia (risedronate sodium) Delayed-release Tablets5/5/11

ChemGenex Pharmaceuticals

Omapro (omacetaxine mepesuccinate) for Injection4/28/11

Forest Laboratories, Inc.

NDA 022256 Savella (milnacipran HCl) Tablets4/28/11

G. Pohl-Boskamp GmbH & Co. KG c/o Arbor Pharmaceuticals, Inc.

NDA 018705 Nitrolingual Pumpspray (nitroglycerin lingual spray)4/26/11

Inspire Pharmaceuticals, Inc.

NDA 050810 AzaSite (azithromycin ophthalmic solution) 1%4/14/11

Three Rivers Pharmaceuticals, LLC

BLA 103663 Infergen (interferon alfacon-1) injection for subcutaneous use3/21/11

Taro Pharmaceuticals USA, Inc.

NDA 18613 Ovide (malathion) lotion, 0.5%3/11/11

Amag Pharmaceuticals, Inc.

NDA 22180 Feraheme (ferumoxytol) Injection for IV use2/17/11

Genentech, Inc.

NDA 21455 Boniva (ibandronate sodium) Tablets1/7/11

DENTSPLY Pharmaceutical

NDA 21451 Oraqix (lidocaine and prilocaine periodontal gel) 2.5%/2.5%1/4/11

  

Office of Drug Security, Integrity and Recalls

 

 Company/IndividualProduct/IssueIssue Date
Eugeniu Rusu/Sphere
(WARNING LETTER)
Internet Marketing of Unapproved and Misbranded Drugs9/21/11

Galyna/Ivan Podornikova
(WARNING LETTER)

Internet Marketing of Unapproved and Misbranded Drugs9/21/11

 

Office of Unapproved Drugs and Labeling Compliance

 

 Company/IndividualProduct/IssueIssue Date
Union Springs Pharmaceuticals, LLC
(WARNING LETTER)
Marketing of MyClyns Personal Protection Spray5/23/11

 

Office of Manufacturing and Product Quality

 Company/IndividualProduct/IssueIssue Date
Labor L+S AG
(WARNING LETTER)
manufacture of Finished Pharmaceuticals12/15/11
Merck KGaA
(WARNING LETTER)
manufacture of APIs and reporting changes to an approved application12/15/11

Novartis International AG
(WARNING LETTER)

manufacture of Finished Pharmaceuticals11/18/11
Akzo Nobel Chemicals, S.A. de C.V.
(WARNING LETTER)
manufacture of APIs11/16/11
Xylo Chem Industries
(WARNING LETTER)

 
manufacture of APIs11/15/11
Jenahexal Pharm GmbH
(WARNING LETTER)
manufacture of Finished Pharmaceuticals10/19/11
SmithKline Beecham Limited
(WARNING LETTER)
manufacture of Finished Pharmaceuticals10/7/11
Yag-Mag Labs Private Limited
(WARNING LETTER)
manufacture of APIs9/12/11
Sichuan Pharmaceutical Co., LTD
(WARNING LETTER)
manufacture of APIs9/9/11
Nanjing Maohai Biotech Co.
(WARNING LETTER)
manufacture of drugs8/5/11
Zhejiang Casing Animal By-Products Co. Ltd.
(WARNING LETTER)
manufacture of drugs8/5/11
Pharmaceutical Company Jelfa SA
(WARNING LETTER)
regulations for Finished Pharmaceuticals7/14/11

Cadila Healthcare Limited
(WARNING LETTER)

regulations for Finished Pharmaceuticals6/21/11
Dr. Reddy's Laboratories Limited
(WARNING LETTER)
manufacture of APIs6/3/11
Aurobindo Pharma Limited
(WARNING LETTER)
regulations for Finished Pharmaceuticals5/20/11
Alpha Laboratories
(WARNING LETTER)
regulations for Finished Pharmaceuticals5/5/11
Moehs Iberica, SL
(WARNING LETTER)
manufacture of APIs4/14/11

Ningbo Smart Pharmaceutical Co. Ltd.
(WARNING LETTER)

manufacture of APIs3/30/11
Sanofi Aventis Deutschland GmbH
(WARNING LETTER)
 
regulations for Finished Pharmaceuticals2/9/11
Teva Pharmaceutical Industries, Ltd
(WARNING LETTER)
regulations for Finished Pharmaceuticals1/31/11

 

 

Office of Compliance/Immediate Office

 Company/IndividualProduct/IssueIssue Date

Changzhou Jialing Medicine Industry Co Ltd
(WARNING LETTER)

Drug Registration and Listing12/2/11

 

 

 

Office of Scientific Investigations

 Company/IndividualProduct/IssueIssue Date
Bay Regional Medical Center IRB
(WARNING LETTER)
Institutional Review Board12/29/11
Betty Tuller, Ph.D.
(WARNING LETTER)
Clinical Investigator11/21/11
Leslie E. Diaz, MD
(WARNING LETTER)
Clinical Investigator11/4/11
Laura A. Teasley, MD
(WARNING LETTER)
Clinical Investigator10/14/11
Columbia University Medical Center RDRC
(WARNING LETTER)
Radioactive Drug Research Committee (RDRC)9/20/11

Covenant Healthcare IRB
(WARNING LETTER)

Institutional Review Board (IRB)9/7/11

John Caton, Jr, MD
(WARNING LETTER)

Clinical Investigator8/26/11
Yale Cohen, MD
(WARNING LETTER)
Clinical Investigator8/12/11
Essex IRB, Inc.
(WARNING LETTER)
Institutional Review Board7/26/11

Cetero Research
(UNTITLED LETTER)

Bioequivalence7/26/11
Linda D. Bosserman, MD
(WARNING LETTER)
Clinical Investigator7/19/11

Joseph B. Michelson, MD
(WARNING LETTER)

Clinical Investigator7/6/11

Jeffrey Horowitz, MD
(WARNING LETTER)

Clinical Investigator3/21/11

Dr. Martin Zaiac
(WARNING LETTER)

Clinical Investigator3/21/11
John Griffin, MD
(WARNING LETTER)
Clinical Investigator3/14/11
Margaret F. Thurmond-Anderle, MD
(WARNING LETTER)
Clinical Investigator2/25/11

John F. Simmons, MD
(WARNING LETTER)

Clinical Investigator2/18/11
Vaughn H. Mancha, Jr., MD
(WARNING LETTER)
Clinical Investigator2/17/11

Judith Ratzan, MD
(WARNING LETTER)

Clinical Investigator2/16/11