Drugs
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
Celgene Corporation Dr. Reddy's Laboratories, Inc. Mutual Pharmaceutical Company, Inc. Sunovion Pharmaceuticals, Inc. NeurogesX, Inc. EUSA Pharma (USA), Inc. Lantheus Medical Imaging, Inc. Otsuka Pharmaceutical Development and Commercialization, Inc. Alcon Research, Ltd. Pfizer, Inc. Ortho-McNeil-Janssen Pharmaceuticals, Inc. CEL-SCI Corporation Promotional Material (PDF - 16MB) Aton Pharma, a Division of Valeant Pharmaceuticals North America LLC ISTA Pharmaceuticals AOI Pharmaceuticals, Inc./Keryx Biopharmaceuticals, Inc. Cephalon, Inc. Nycomed US, Inc. Dow Pharmaceutical Sciences, Inc. Noven Pharmaceuticals, Inc. Shire Pharmaceuticals, Inc. Warner Chilcott (US, LLC ChemGenex Pharmaceuticals Forest Laboratories, Inc. G. Pohl-Boskamp GmbH & Co. KG c/o Arbor Pharmaceuticals, Inc. Inspire Pharmaceuticals, Inc. Three Rivers Pharmaceuticals, LLC Taro Pharmaceuticals USA, Inc. Amag Pharmaceuticals, Inc. Genentech, Inc. DENTSPLY Pharmaceutical Company/Individual Product/Issue Issue Date NDA 021660 Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 12/23/11 ANDA 91316 Fondaparinux Sodium Solution for subcutaneous injection 12/22/11 NDA 022352 Colcrys (colchicine, USP) tablets for Oral use 12/20/11 NDA 200603 Latuda (lurasidone HCl) Tablets 12/14/11 NDA 022395 Qutenza (capsaicin) 8% patch 12/13/11 BLA 103608 ProstaScint Kit (Capromab Pendetide) 12/13/11 NDA 17771 Technelite (Technetium Tc 99m Generator) 10/25/11 NDA 020954 Busulfex (busulfan) Injection 10/17/11 NDA 021545 Pataday (olopatadine hydrochloride ophthalmic solution) 0.2% 10/14/11 NDA 021928 Chantix (varenicline) Tablets, NDA 021540 Caduet (amlodipine besylate/atorvastatin calcium) Tablets, NDA 019787 Norvasc (amlodipine besylate) Tablets 8/31/11 NDA 022304 Nucynta (tapentadol) immediate-release oral tablets C-II 8/26/2011 Multikine (Leukocyte Interleukin) Injection 8/5/11 NDA 010104 Mephyton (phytonadione) Vitamin K1 Tablets 8/2/11 NDA 021664 Bromday (bromfenac ophthalmic solution) 0.09% 7/13/11 KRX-0401 (perifosine) 6/30/11 NDA 021248 Trisenox (arsenic trioxide) injection 6/21/11 NDA 021005 Solaraze (diclofenac sodium) Gel, 3% 6/17/11 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 NDA 021299 Pexeva (paroxetine mesylate) Tablets 5/24/11 NDA 021977 Vyvanse (lisdexamfetamine dimesylate) Capsules, CII 5/6/11 NDA 022560 Atelvia (risedronate sodium) Delayed-release Tablets 5/5/11 Omapro (omacetaxine mepesuccinate) for Injection 4/28/11 NDA 022256 Savella (milnacipran HCl) Tablets 4/28/11 NDA 018705 Nitrolingual Pumpspray (nitroglycerin lingual spray) 4/26/11 NDA 050810 AzaSite (azithromycin ophthalmic solution) 1% 4/14/11 BLA 103663 Infergen (interferon alfacon-1) injection for subcutaneous use 3/21/11 NDA 18613 Ovide (malathion) lotion, 0.5% 3/11/11 NDA 22180 Feraheme (ferumoxytol) Injection for IV use 2/17/11 NDA 21455 Boniva (ibandronate sodium) Tablets 1/7/11 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
(WARNING LETTER)Internet Marketing of Unapproved and Misbranded Drugs 9/21/11 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
(WARNING LETTER)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 (WARNING LETTER) | manufacture of Finished Pharmaceuticals | 12/15/11 |
| Merck KGaA (WARNING LETTER) | manufacture of APIs and reporting changes to an approved application | 12/15/11 |
| manufacture of Finished Pharmaceuticals | 11/18/11 | |
| Akzo Nobel Chemicals, S.A. de C.V. (WARNING LETTER) | manufacture of APIs | 11/16/11 |
| Jenahexal Pharm GmbH (WARNING LETTER) | manufacture of Finished Pharmaceuticals | 10/19/11 |
| SmithKline Beecham Limited (WARNING LETTER) | manufacture of Finished Pharmaceuticals | 10/7/11 |
| Yag-Mag Labs Private Limited (WARNING LETTER) | manufacture of APIs | 9/12/11 |
| Sichuan Pharmaceutical Co., LTD (WARNING LETTER) | manufacture of APIs | 9/9/11 |
| Nanjing Maohai Biotech Co. (WARNING LETTER) | manufacture of drugs | 8/5/11 |
| Zhejiang Casing Animal By-Products Co. Ltd. (WARNING LETTER) | manufacture of drugs | 8/5/11 |
| Pharmaceutical Company Jelfa SA (WARNING LETTER) | regulations for Finished Pharmaceuticals | 7/14/11 |
| regulations for Finished Pharmaceuticals | 6/21/11 | |
| Dr. Reddy's Laboratories Limited (WARNING LETTER) | manufacture of APIs | 6/3/11 |
| Aurobindo Pharma Limited (WARNING LETTER) | regulations for Finished Pharmaceuticals | 5/20/11 |
| Alpha Laboratories (WARNING LETTER) | regulations for Finished Pharmaceuticals | 5/5/11 |
| Moehs Iberica, SL (WARNING LETTER) | manufacture of APIs | 4/14/11 |
| manufacture of APIs | 3/30/11 | |
| Sanofi Aventis Deutschland GmbH (WARNING LETTER) | regulations for Finished Pharmaceuticals | 2/9/11 |
| Teva Pharmaceutical Industries, Ltd (WARNING LETTER) | regulations for Finished Pharmaceuticals | 1/31/11 |
Office of Compliance/Immediate Office
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| Drug Registration and Listing | 12/2/11 |
Office of Scientific Investigations
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| Bay Regional Medical Center IRB (WARNING LETTER) | Institutional Review Board | 12/29/11 |
| Betty Tuller, Ph.D. (WARNING LETTER) | Clinical Investigator | 11/21/11 |
| Leslie E. Diaz, MD (WARNING LETTER) | Clinical Investigator | 11/4/11 |
| Laura A. Teasley, MD (WARNING LETTER) | Clinical Investigator | 10/14/11 |
| Columbia University Medical Center RDRC (WARNING LETTER) | Radioactive Drug Research Committee (RDRC) | 9/20/11 |
| Institutional Review Board (IRB) | 9/7/11 | |
| Clinical Investigator | 8/26/11 | |
| Yale Cohen, MD (WARNING LETTER) | Clinical Investigator | 8/12/11 |
| Essex IRB, Inc. (WARNING LETTER) | Institutional Review Board | 7/26/11 |
| Bioequivalence | 7/26/11 | |
| Linda D. Bosserman, MD (WARNING LETTER) | Clinical Investigator | 7/19/11 |
| Clinical Investigator | 7/6/11 | |
| Clinical Investigator | 3/21/11 | |
| Clinical Investigator | 3/21/11 | |
| John Griffin, MD (WARNING LETTER) | Clinical Investigator | 3/14/11 |
| Margaret F. Thurmond-Anderle, MD (WARNING LETTER) | Clinical Investigator | 2/25/11 |
| Clinical Investigator | 2/18/11 | |
| Vaughn H. Mancha, Jr., MD (WARNING LETTER) | Clinical Investigator | 2/17/11 |
| Clinical Investigator | 2/16/11 |
