Warning Letters 2012
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.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 |
|---|---|---|
| Salix Pharmaceuticals, Inc. Napo Pharmaceuticals, Inc.
| Crofelemer Tablets | 11/27/12 |
Alcon Research, Ltd.
| NDA 021861 Patanase (olopatadine hydrochloride) Nasal Spray | 11/13/12 |
Cornerstone Therapeutics, Inc.
| NDA 020744 Curosurf (poractant alfa) Intratracheal suspension | 10/31/12 |
Ony, Inc.
| NDA 020521 Infasurf (calfactant) Intratracheal suspension | 10/31/12 |
Burzynski Research Institute, Inc.
| IND 43742 Antineoplastons A10 and AS2-1 injections | 10/18/12 |
Genentech, Inc.
| NDA 021743 Tarceva (erlotinib) tablets | 10/3/12 |
Endo Pharmaceuticals, Inc.
| NDA 021732 Vantas (histrelin acetate) subcutaneous implant | 9/25/12 |
Jazz Pharmaceuticals
| NDA 021590 FazaClo (clozapine, USP) Orally Disintegrating tablets | 9/18/12 |
Eli Lilly and Company
| NDA 202008 Amyvid (Florbetapir F 18 Injection) for intravenous use | 8/10/12 |
Forest Laboratories, Inc.
| NDA 022522 Daliresp (roflumilast) tablets | 8/1/12 |
Valeant Pharmaceuticals North America, LLC
| NDA 021478 Zovirax (acyclovir) Cream 5% | 7/18/12 |
Bristol-Myers Squibb
| NDA 022065 Ixempra (ixabepilone) | 6/29/12 |
Validus Pharmaceuticals, LLC
| NDA 021710 Equetro (carbamazepine) Extended-Release capsules | 6/25/12 |
Acorda Therapeutics, Inc.
| NDA 022250 Ampyra (dalfampridine) Extended Release tablets | 6/21/12 |
Valeant Pharmaceuticals North America, LLC
| NDA 021894 Xenazine (tetrabenazine) Tablets, for oral use | 6/21/12 |
Pfizer, Inc.
| NDA 050797 Zmax (azithromycin extended release) for oral suspension | 6/19/12 |
Quintiles, Inc. [U.S. Agent for Swedish Orphan Biovitrum AB]
| BLA 125103 Kepivance (palifermin) For Injection, for intravenous use | 6/7/12 |
Watson Pharmaceuticals, Inc.
| ANDA 078215 Sodium Ferric Gluconate Complex in Sucrose injection | 6/7/12 |
Vertex Pharmaceuticals, Inc.
| NDA 201917 Incivik (telaprevir) Film Coated tablets | 5/25/12 |
Pfizer, Inc.
| NDA 019430 EpiPen and EpiPen Jr. (epinephrine) Auto-Injectors | 5/24/12 |
Meda Pharmaceuticals, Inc.
| NDA 022203 Astepro (azelastine hydrochloride) Nasal Spray 0.15% | 4/26/12 |
The Medicines Company
| NDA 020873 Angiomax (bivalirudin) for injection | 4/13/12 |
Ferring Pharmaceuticals, Inc.
| NDA 022201 Firmagon (degarelix for injection) for subcutaneous administration | 3/30/12 |
Biogen Idec
| BLA 103628 Avonex (Interferon beta-1a) IM injection | 3/14/12 |
Teva Pharmaceuticals USA
| NDA 020622 Copaxone (glatiramer acetate injection) solution for subcutaneous injection | 3/14/12 |
Dow Pharmaceutical Sciences, Inc.
| NDA 022070 Atralin (tretinoin) gel, 0.05% | 3/6/12 |
Merck & Co., Inc.
| NDA 022117 Saphris (asenapine) sublingual tablets | 2/28/12 |
Novartis Oncology
| NDA 021588 Gleevec (imatinib mesylate) tablets for oral use | 1/9/12 |
Office of Compliance/Immediate Office
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| Quzhou Chemsyn Pharm Co., Ltd (WARNING LETTER) | failure to register and list | 9/6/12 |
| Aino Co., Ltd. of North China Pharmaceutical Group (WARNING LETTER) | failure to register | 8/30/12 |
| Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd. (WARNING LETTER) | failure to register | 6/14/12 |
| Zhucheng Haotian Pharm Co., Ltd. (WARNING LETTER) | failure to register | 6/11/12 |
| Faci S.P.A. (WARNING LETTER) | failure to register | 5/24/12 |
| C.I. Farmacapsulas S.A. (WARNING LETTER) | failure to register | 5/15/12 |
| Sal Pharma (WARNING LETTER) | failure to register | 4/24/12 |
| Peking Medicine Manufactory (WARNING LETTER) | failure to register | 4/5/12 |
| Korea Pharma Company Ltd (WARNING LETTER) | failure to register | 3/26/12 |
| Orlane S.A. (WARNING LETTER) | failure to register | 3/15/12 |
| Pan Drugs Limited (WARNING LETTER) | failure to register | 2/28/12 |
| Chinese Peptide Company (WARNING LETTER) | failure to register | 2/28/12 |
| Zhejiang Xianju Chemical Pharmaceutical Factory (WARNING LETTER) | failure to register | 1/25/12 |
Office of Drug Security, Integrity and Recalls
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| Canadadrugs (WARNING LETTER) | Internet Marketing of Unapproved and Misbranded Drugs | 9/21/12 |
| Pronet/Eyal Bar Oz (WARNING LETTER) | Internet Marketing of Unapproved and Misbranded Drugs | 9/18/12 |
| Arkadiy Kisin/White Forest Solution (WARNING LETTER) | Internet Marketing of Unapproved and Misbranded Drugs | 9/18/12 |
| Marks Marine Pharmacy (WARNING LETTER) | Illegal Promotion of an Unapproved and Misbranded Drug | 8/23/12 |
| NorthwestPharmacy.com (WARNING LETTER) | Internet Marketing of an Unapproved and Misbranded Drug | 5/24/12 |
| Best Price Rx (WARNING LETTER) | Internet Marketing of an Unapproved and Misbranded Drug | 5/24/12 |
Office of Manufacturing and Product Quality
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| regulations for finished pharmaceuticals | 12/19/12 | |
| regulations for finished pharmaceuticals | 12/17/12 | |
| regulations for finished pharmaceuticals | 12/17/12 | |
| Shanghai Huhui Daily Use Chemical Products Co., Ltd. (WARNING LETTER) | regulations for finished pharmaceuticals | 11/14/12 |
| International Laboratories (Canada) Ltd. (WARNING LETTER) | regulations for finished pharmaceuticals | 10/23/12 |
| Fercy Personal Care Products Co., Ltd (WARNING LETTER) | regulations for finished pharmaceuticals | 9/7/12 |
| Jiangsu Province Jianerkang Medical Dressing Co., Ltd. (WARNING LETTER) | regulations for finished pharmaceuticals | 7/30/12 |
| A Nelson & Co., Ltd (WARNING LETTER) | regulations for finished pharmaceuticals | 7/26/12 |
| Ecros S.A. (WARNING LETTER) | manufacture of APIs | 6/20/12 |
| Hemofarm A.D. (WARNING LETTER) | regulations for finished pharmaceuticals | 6/20/12 |
| Compañía Internacional de Comercio, S.A. de C.V. (WARNING LETTER) | regulations for finished pharmaceuticals | 6/13/12 |
| B.M.P. Pharma Trading AG (WARNING LETTER) | manufacture of APIs | 5/4/12 |
| Selder S.A. de C.V. (WARNING LETTER) | regulations for finished pharmaceuticals | 4/27/12 |
| Tedec-Meiji Farma, S.A. (WARNING LETTER) | regulations for finished pharmaceuticals | 4/24/12 |
| UNAM, Facultad De Estudios Superiores Cuautitlan (WARNING LETTER) | manufacture of APIs | 3/24/12 |
| Farma Quimia S.A. de C.V. (WARNING LETTER) | manufacture of APIs | 3/9/12 |
| Pax-All Manufacturing, Inc. (WARNING LETTER) | significant violations of Current Good Manufacturing Practice (CGMP) | 3/9/12 |
| Laboratorios Jaloma S.A. de C.V. (WARNING LETTER) | significant violations of Current Good Manufacturing Practice (CGMP) | 3/9/12 |
| Nobilus Ent (WARNING LETTER) | manufacture of APIs | 3/7/12 |
| Wintac Limited (WARNING LETTER) | regulations for finished pharmaceuticals | 2/23/12 |
| Gulf Pharmaceutical Industries (WARNING LETTER) | significant violations of Current Good Manufacturing Practice (CGMP) | 2/23/12 |
Office of Scientific Investigations
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| Salem Hospital IRB (WARNING LETTER) | Institutional Review Board (IRB) | 11/29/12 |
| Steven W. Boyce, MD (WARNING LETTER) | Clinical Investigator | 9/28/12 |
| Memorial Hospital of South Bend IRB (WARNING LETTER) | Institutional Review Board (IRB) | 9/21/12 |
| Center for the Improvement of Human Functioning International, Inc. (WARNING LETTER) | Institutional Review Board (IRB) | 7/3/12 |
| Advocate Health Care (WARNING LETTER) | Institutional Review Board (IRB) | 6/1/12 |
| Our Lady of Bellefonte Hospital (WARNING LETTER) | Institutional Review Board (IRB) | 6/1/12 |
| Elizabeth E. Houser, MD (WARNING LETTER) | Clinical Investigator | 5/25/12 |
| Merck Sharp and Dohme Corp. (WARNING LETTER) | Postmarket Requirements (PMRs) | 2/17/12 |
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