Drugs
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.
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
Salix Pharmaceuticals, Inc. Napo Pharmaceuticals, Inc. Alcon Research, Ltd. Cornerstone Therapeutics, Inc. Ony, Inc. Burzynski Research Institute, Inc. Genentech, Inc. Endo Pharmaceuticals, Inc. Jazz Pharmaceuticals Eli Lilly and Company Forest Laboratories, Inc. Valeant Pharmaceuticals North America, LLC Bristol-Myers Squibb Validus Pharmaceuticals, LLC Valeant Pharmaceuticals North America, LLC Quintiles, Inc. [U.S. Agent for Swedish Orphan Biovitrum AB] Vertex Pharmaceuticals, Inc. Pfizer, Inc. Meda Pharmaceuticals, Inc. Ferring Pharmaceuticals, Inc. Teva Pharmaceuticals USA Dow Pharmaceutical Sciences, Inc. Merck & Co., Inc. Novartis Oncology Company/Individual Product/Issue Issue Date
Crofelemer Tablets 11/27/12
NDA 021861 Patanase (olopatadine hydrochloride) Nasal Spray 11/13/12 NDA 020744 Curosurf (poractant alfa) Intratracheal suspension 10/31/12 NDA 020521 Infasurf (calfactant) Intratracheal suspension 10/31/12 IND 43742 Antineoplastons A10 and AS2-1 injections 10/18/12 NDA 021743 Tarceva (erlotinib) tablets 10/3/12 NDA 021732 Vantas (histrelin acetate) subcutaneous implant 9/25/12 NDA 021590 FazaClo (clozapine, USP) Orally Disintegrating tablets 9/18/12 NDA 202008 Amyvid (Florbetapir F 18 Injection) for intravenous use 8/10/12 NDA 022522 Daliresp (roflumilast) tablets 8/1/12 NDA 021478 Zovirax (acyclovir) Cream 5% 7/18/12 NDA 022065 Ixempra (ixabepilone) 6/29/12 NDA 021710 Equetro (carbamazepine) Extended-Release capsules 6/25/12 Acorda Therapeutics, Inc. NDA 022250 Ampyra (dalfampridine) Extended Release tablets 6/21/12 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 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 NDA 201917 Incivik (telaprevir) Film Coated tablets 5/25/12 NDA 019430 EpiPen and EpiPen Jr. (epinephrine) Auto-Injectors 5/24/12 NDA 022203 Astepro (azelastine hydrochloride) Nasal Spray 0.15% 4/26/12 The Medicines Company NDA 020873 Angiomax (bivalirudin) for injection 4/13/12 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 NDA 020622 Copaxone (glatiramer acetate injection) solution for subcutaneous injection 3/14/12 NDA 022070 Atralin (tretinoin) gel, 0.05% 3/6/12 NDA 022117 Saphris (asenapine) sublingual tablets 2/28/12 NDA 021588 Gleevec (imatinib mesylate) tablets for oral use 1/9/12
Office of Compliance/Immediate Office
Office of Drug Security, Integrity and Recalls
Company/Individual Product/Issue Issue Date Internet Marketing of Unapproved and Misbranded Drugs 9/21/12 Internet Marketing of Unapproved and Misbranded Drugs 9/18/12 Internet Marketing of Unapproved and Misbranded Drugs 9/18/12 Illegal Promotion of an Unapproved and Misbranded Drug 8/23/12 Internet Marketing of an Unapproved and Misbranded Drug 5/24/12 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 | |
| regulations for finished pharmaceuticals | 12/12/12 | |
| 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 |
| 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 |
| 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. | 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 |
| Clinical Investigator | 5/25/12 | |
| Merck Sharp and Dohme Corp. (WARNING LETTER) | Postmarket Requirements (PMRs) | 2/17/12 |
