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/Individual Product/Issue Issue 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 injection 12/22/11

Mutual Pharmaceutical Company, Inc.

NDA 022352 Colcrys (colchicine, USP) tablets for Oral use 12/20/11

Sunovion Pharmaceuticals, Inc.

NDA 200603 Latuda (lurasidone HCl) Tablets 12/14/11

NeurogesX, Inc.

NDA 022395 Qutenza (capsaicin) 8% patch 12/13/11

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) Injection 10/17/11

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) Tablets 8/31/11

Ortho-McNeil-Janssen Pharmaceuticals, Inc.

NDA 022304 Nucynta (tapentadol) immediate-release oral tablets C-II 8/26/2011

 CEL-SCI Corporation

Multikine (Leukocyte Interleukin) Injection 8/5/11

Aton Pharma, a Division of Valeant Pharmaceuticals North America LLC

NDA 010104 Mephyton (phytonadione) Vitamin K1 Tablets 8/2/11

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) injection 6/21/11

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 Cll 5/31/11

Noven Pharmaceuticals, Inc.

NDA 021299 Pexeva (paroxetine mesylate) Tablets 5/24/11

Shire Pharmaceuticals, Inc.

NDA 021977 Vyvanse (lisdexamfetamine dimesylate) Capsules, CII 5/6/11

Warner Chilcott (US, LLC

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

ChemGenex Pharmaceuticals

Omapro (omacetaxine mepesuccinate) for Injection 4/28/11

Forest Laboratories, Inc.

NDA 022256 Savella (milnacipran HCl) Tablets 4/28/11

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 use 3/21/11

Taro Pharmaceuticals USA, Inc.

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

Amag Pharmaceuticals, Inc.

NDA 22180 Feraheme (ferumoxytol) Injection for IV use 2/17/11

Genentech, Inc.

NDA 21455 Boniva (ibandronate sodium) Tablets 1/7/11

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/Individual Product/Issue Issue Date
Eugeniu Rusu/Sphere
Internet Marketing of Unapproved and Misbranded Drugs 9/21/11

Galyna/Ivan Podornikova

Internet Marketing of Unapproved and Misbranded Drugs 9/21/11


Office of Unapproved Drugs and Labeling Compliance


 Company/Individual Product/Issue Issue Date
Union Springs Pharmaceuticals, LLC
Marketing of MyClyns Personal Protection Spray 5/23/11


Office of Manufacturing and Product Quality

 Company/Individual Product/Issue Issue Date
Labor L+S AG
manufacture of Finished Pharmaceuticals 12/15/11
Merck KGaA
manufacture of APIs and reporting changes to an approved application 12/15/11

Novartis International AG

manufacture of Finished Pharmaceuticals 11/18/11
Akzo Nobel Chemicals, S.A. de C.V.
manufacture of APIs 11/16/11
Xylo Chem Industries

manufacture of APIs 11/15/11
Jenahexal Pharm GmbH
manufacture of Finished Pharmaceuticals 10/19/11
SmithKline Beecham Limited
manufacture of Finished Pharmaceuticals 10/7/11
Yag-Mag Labs Private Limited
manufacture of APIs 9/12/11
Sichuan Pharmaceutical Co., LTD
manufacture of APIs 9/9/11
Nanjing Maohai Biotech Co.
manufacture of drugs 8/5/11
Zhejiang Casing Animal By-Products Co. Ltd.
manufacture of drugs 8/5/11
Pharmaceutical Company Jelfa SA
regulations for Finished Pharmaceuticals 7/14/11

Cadila Healthcare Limited

regulations for Finished Pharmaceuticals 6/21/11
Dr. Reddy's Laboratories Limited
manufacture of APIs 6/3/11
Aurobindo Pharma Limited
regulations for Finished Pharmaceuticals 5/20/11
Alpha Laboratories
regulations for Finished Pharmaceuticals 5/5/11
Moehs Iberica, SL
manufacture of APIs 4/14/11

Ningbo Smart Pharmaceutical Co. Ltd.

manufacture of APIs 3/30/11
Sanofi Aventis Deutschland GmbH
regulations for Finished Pharmaceuticals 2/9/11
Teva Pharmaceutical Industries, Ltd
regulations for Finished Pharmaceuticals 1/31/11



Office of Compliance/Immediate Office

 Company/Individual Product/Issue Issue Date

Changzhou Jialing Medicine Industry Co Ltd

Drug Registration and Listing 12/2/11




Office of Scientific Investigations

 Company/Individual Product/Issue Issue Date
Bay Regional Medical Center IRB
Institutional Review Board 12/29/11
Betty Tuller, Ph.D.
Clinical Investigator 11/21/11
Leslie E. Diaz, MD
Clinical Investigator 11/4/11
Laura A. Teasley, MD
Clinical Investigator 10/14/11
Columbia University Medical Center RDRC
Radioactive Drug Research Committee (RDRC) 9/20/11

Covenant Healthcare IRB

Institutional Review Board (IRB) 9/7/11

John Caton, Jr, MD

Clinical Investigator 8/26/11
Yale Cohen, MD
Clinical Investigator 8/12/11
Essex IRB, Inc.
Institutional Review Board 7/26/11

Cetero Research

Bioequivalence 7/26/11
Linda D. Bosserman, MD
Clinical Investigator 7/19/11

Joseph B. Michelson, MD

Clinical Investigator 7/6/11

Jeffrey Horowitz, MD

Clinical Investigator 3/21/11

Dr. Martin Zaiac

Clinical Investigator 3/21/11
John Griffin, MD
Clinical Investigator 3/14/11
Margaret F. Thurmond-Anderle, MD
Clinical Investigator 2/25/11

John F. Simmons, MD

Clinical Investigator 2/18/11
Vaughn H. Mancha, Jr., MD
Clinical Investigator 2/17/11

Judith Ratzan, MD

Clinical Investigator 2/16/11

Page Last Updated: 03/14/2016
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