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U.S. Department of Health and Human Services

Drugs

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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

 Company/IndividualProduct/IssueIssue Date

Salix Pharmaceuticals, Inc.
 

Napo Pharmaceuticals, Inc.

Crofelemer Tablets11/27/12

Alcon Research, Ltd.
 

NDA 021861 Patanase (olopatadine hydrochloride) Nasal Spray11/13/12

Cornerstone Therapeutics, Inc.

NDA 020744 Curosurf (poractant alfa) Intratracheal suspension10/31/12

Ony, Inc.

NDA 020521 Infasurf (calfactant) Intratracheal suspension10/31/12

Burzynski Research Institute, Inc.

IND 43742 Antineoplastons A10 and AS2-1 injections10/18/12

Genentech, Inc.

NDA 021743 Tarceva (erlotinib) tablets10/3/12

Endo Pharmaceuticals, Inc.

NDA 021732 Vantas (histrelin acetate) subcutaneous implant9/25/12

Jazz Pharmaceuticals

NDA 021590 FazaClo (clozapine, USP) Orally Disintegrating tablets9/18/12

Eli Lilly and Company

NDA 202008 Amyvid (Florbetapir F 18 Injection) for intravenous use8/10/12

Forest Laboratories, Inc.

NDA 022522 Daliresp (roflumilast) tablets8/1/12

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 capsules6/25/12
Acorda Therapeutics, Inc. NDA  022250 Ampyra (dalfampridine) Extended Release tablets6/21/12

Valeant Pharmaceuticals North America, LLC

NDA 021894 Xenazine (tetrabenazine) Tablets, for oral use6/21/12
Pfizer, Inc. NDA 050797 Zmax (azithromycin extended release) for oral suspension6/19/12

Quintiles, Inc. [U.S. Agent for Swedish Orphan Biovitrum AB]

BLA 125103 Kepivance (palifermin) For Injection, for intravenous use6/7/12
Watson Pharmaceuticals, Inc. ANDA 078215 Sodium Ferric Gluconate Complex in Sucrose injection6/7/12

Vertex Pharmaceuticals, Inc.

NDA 201917 Incivik (telaprevir) Film Coated tablets5/25/12

Pfizer, Inc.

NDA 019430 EpiPen and EpiPen Jr. (epinephrine) Auto-Injectors5/24/12

Meda Pharmaceuticals, Inc.

NDA 022203 Astepro (azelastine hydrochloride) Nasal Spray 0.15%4/26/12
The Medicines Company NDA 020873 Angiomax (bivalirudin) for injection4/13/12

Ferring Pharmaceuticals, Inc.

NDA 022201 Firmagon (degarelix for injection) for subcutaneous administration3/30/12
Biogen Idec BLA 103628 Avonex (Interferon beta-1a) IM injection3/14/12

Teva Pharmaceuticals USA

NDA 020622 Copaxone (glatiramer acetate injection) solution for subcutaneous injection3/14/12

Dow Pharmaceutical Sciences, Inc.

NDA 022070 Atralin (tretinoin) gel, 0.05%3/6/12

Merck & Co., Inc.

NDA 022117 Saphris (asenapine) sublingual tablets2/28/12

Novartis Oncology

NDA 021588 Gleevec (imatinib mesylate) tablets for oral use1/9/12

  

 

Office of Compliance/Immediate Office

 

 Company/IndividualProduct/IssueIssue Date
Quzhou Chemsyn Pharm Co., Ltd
(WARNING LETTER)
 
failure to register and list9/6/12
Aino Co., Ltd. of North China Pharmaceutical Group
(WARNING LETTER)

 
failure to register8/30/12
Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.
(WARNING LETTER)
failure to register6/14/12
Zhucheng Haotian Pharm Co., Ltd.
(WARNING LETTER)
failure to register6/11/12
Changzhou Wujin Zhengping Shuangma Chemical Plant
(WARNING LETTER)

 
failure to register and list5/31/12
Faci S.P.A.
(WARNING LETTER)
failure to register5/24/12
C.I. Farmacapsulas S.A.
(WARNING LETTER)
failure to register5/15/12
Sal Pharma
(WARNING LETTER)
failure to register4/24/12
Peking Medicine Manufactory
(WARNING LETTER)
failure to register4/5/12
Korea Pharma Company Ltd
(WARNING LETTER)
failure to register3/26/12
Orlane S.A.
(WARNING LETTER)
failure to register3/15/12
Pan Drugs Limited
(WARNING LETTER)
failure to register2/28/12
Chinese Peptide Company
(WARNING LETTER)
failure to register2/28/12
Zhejiang Xianju Chemical Pharmaceutical Factory
(WARNING LETTER)
failure to register1/25/12

 

 

Office of Drug Security, Integrity and Recalls 

 Company/IndividualProduct/IssueIssue Date

Canadadrugs
(WARNING LETTER)

 

Internet Marketing of Unapproved and Misbranded Drugs9/21/12

Pronet/Eyal Bar Oz
(WARNING LETTER)

 

Internet Marketing of Unapproved and Misbranded Drugs9/18/12

Arkadiy Kisin/White Forest Solution
(WARNING LETTER)

 

Internet Marketing of Unapproved and Misbranded Drugs9/18/12

Marks Marine Pharmacy
(WARNING LETTER)

 

Illegal Promotion of an Unapproved and Misbranded Drug8/23/12

NorthwestPharmacy.com
(WARNING LETTER)

Internet Marketing of an Unapproved and Misbranded Drug5/24/12

Best Price Rx
(WARNING LETTER)

Internet Marketing of an Unapproved and Misbranded Drug5/24/12

 
 

Office of Manufacturing and Product Quality

 Company/IndividualProduct/IssueIssue Date
regulations for finished pharmaceuticals12/19/12
regulations for finished pharmaceuticals12/17/12
regulations for finished pharmaceuticals12/17/12
regulations for finished pharmaceuticals12/12/12
Shanghai Huhui Daily Use Chemical Products Co., Ltd.
(WARNING LETTER)

 
regulations for finished pharmaceuticals11/14/12
International Laboratories (Canada) Ltd.
(WARNING LETTER)

 
regulations for finished pharmaceuticals10/23/12
Fercy Personal Care Products Co., Ltd
(WARNING LETTER)
regulations for finished pharmaceuticals9/7/12
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
(WARNING LETTER)
regulations for finished pharmaceuticals7/30/12
A Nelson & Co., Ltd
(WARNING LETTER)
regulations for finished pharmaceuticals7/26/12
Ecros S.A.
(WARNING LETTER)
manufacture of APIs6/20/12
Hemofarm A.D.
(WARNING LETTER)
regulations for finished pharmaceuticals6/20/12
Compañía Internacional de Comercio, S.A. de C.V.
(WARNING LETTER)
regulations for finished pharmaceuticals6/13/12
B.M.P. Pharma Trading AG
(WARNING LETTER)
manufacture of APIs5/4/12
Selder S.A. de C.V.
(WARNING LETTER)
regulations for finished pharmaceuticals4/27/12
Tedec-Meiji Farma, S.A.
(WARNING LETTER)
regulations for finished pharmaceuticals4/24/12
UNAM, Facultad De Estudios Superiores Cuautitlan
(WARNING LETTER)
manufacture of APIs3/24/12

Farma Quimia S.A. de C.V.
(WARNING LETTER)

manufacture of APIs3/9/12
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 APIs3/7/12

Wintac Limited
(WARNING LETTER)

regulations for finished pharmaceuticals2/23/12
Gulf Pharmaceutical Industries
(WARNING LETTER)
significant violations of Current Good Manufacturing Practice (CGMP)2/23/12
  

 

Office of Scientific Investigations

 Company/IndividualProduct/IssueIssue Date
Salem Hospital IRB
(WARNING LETTER)

 
Institutional Review Board (IRB)11/29/12
Steven W. Boyce, MD
(WARNING LETTER)

 
Clinical Investigator9/28/12
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 Investigator5/25/12
Merck Sharp and Dohme Corp.
(WARNING LETTER)
Postmarket Requirements (PMRs)2/17/12