Drugs

Warning Letters 2013

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

DaraBiosciences, Inc.

NDA 021807 Soltamox (tamoxifen citrate) oral solution12/20/13

Pernix Therapeutics Holdings, Inc.

NDA 050685, 050686 Cedax (ceftibuten) Capsules and Oral Suspension12/20/13

Amarin Pharmaceuticals Ireland LTD

NDA 202057 Vascepa (icosapent ethyl) Capsules, for oral use12/16/13

Covis Pharmaceuticals

NDA 020405 Lanoxin (digoxin) Tablets, for oral use12/9/13

Amgen, Inc.

BLA 103951 Aranesp (darbepoetin alfa)11/19/13

Kadmon Pharmaceuticals, LLC

ANDA 077456 Ribasphere RibaPak (ribavirin, USP) Tablets11/18/13

Duchesnay, Inc.

NDA 021876 Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets for oral use11/12/13

US WorldMeds, LLC

ANDA 078378 Revonto (dantrolene sodium) for injection11/8/13

 Aegerion Pharmaceuticals, Inc.

NDA 203858 Juxtapid (lomitapide) capsules, for oral use

11/8/13
Daiichi Sankyo, Inc.
NDA 021286 & 021532 Benicar (olmesartan medoxomil) tablets, for oral use and Benicar HCT (olmesartan medoxomil - hydrochlorothiazide) Tablets11/5/13
Sunovion Pharmaceuticals, Inc.
NDA 021912 Brovana (arformoterol tartrate) Inhalation Solution10/24/13

Merz Pharmaceuticals, LLC

NDA 019599 Naftin (naftifine hydrochloride) Cream, 2%7/31/13

Acorda Therapeutics, Inc.

NDA 022250 Ampyra (dalfampridine) Extended Release Tablets7/25/13

Spectrum Pharmaceuticals

BLA 125019 Zevalin (ibritumomab tiuxetan) Injection for Intravenous Use7/23/13

Johnson & Johnson International, Inc.

NDA 202439 XARELTO (rivaroxaban) tablets6/6/13

HCC Regulatory Advertising & Promotion, J&J Intl. On behalf of Janssen Biotech Products, L.P.

NDA 050718 Doxil (doxorubicin HCl liposome injection) for Intravenous Injection5/22/13

Sigma-tau Pharmaceuticals, Inc.

BLA 103411 Oncaspar (pegaspargase) injection, for intramuscular or intravenous use5/22/13

Validus Pharmaceuticals, LLC

NDA 011961 Marplan (isocarboxazid) tablets5/6/13

Mobius Therapeutics, LLC

NDA 022572 Mitosol (mitomycin for solution)5/2/13

CBA Research, Inc.

CBT-1 Capsules4/25/13

Teva Neuroscience, Inc.

ANDA 076809 Clozapine Tablets USP4/8/13

Photocure ASA c/o Cato Westpark Corporate Center

NDA 022555 Cysview (hexaminolevulinate hydrochloride), for Intravesical Solution3/4/13

ParaPRO, LLC

NDA 022408 Natroba (spinosad) topical suspension, 0.9%2/21/13
Alcon Research Ltd. NDA 021545 Pataday (olopatadine hydrochloride ophthalmic solution) 0.2%2/5/13

Office of Compliance/Immediate Office 

Company/IndividualProduct/IssueIssue Date
Homeolab, Inc.
(WARNING LETTER)

 
labeling and marketing information for the drug product, “Kids Relief Earache"9/19/13
C.P.M. Contract Pharma GmbH & Co. KG
(WARNING LETTER)
 
failed to self-identify the facility and pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 20129/17/13

Changzhou Qianhong Bio-Pharma Co., Ltd
(WARNING LETTER)

Drug Registration and Listing6/4/13
Medsnoscript
(WARNING LETTER)

 

Internet Marketing of unapproved drug drug (Generic Tamiflu) on www.Medsnoscript.com

2/11/13

Secure Medical Inc.
(WARNING LETTER)

Internet Marketing of unapproved drug (Tamiflu 75mg Gel Tablet) on www.viamedic.com, www.accessrx.com, and www.AmeriMedixRx.com 

2/11/13

Sun Drug Store
(WARNING LETTER)

Internet Marketing of unapproved drug (Generic Tamiflu) on www.SunDrugStore.com

2/11/13

Discount Online Pharmacy
(WARNING LETTER)

Internet Marketing of unapproved drug (Generic Tamiflu) on www.topsavingspharmacy.com

2/11/13

Oasis Consumer Healthcare, LLC
(WARNING LETTER)

Internet Marketing of unapproved drug (Halo) on www.halogermdefense.com

2/11/13

buy-pharma.com
(WARNING LETTER)

Internet Marketing of unapproved drug (Pirfenidone) on www.buy-pharma.com, on January 8, 2013

2/4/13

Big Mountain Drugs
(WARNING LETTER)

Internet Marketing of unapproved drug (Pirfenidone) on www.bigmountaindrugs.com, and www.buypirfenidone.com, on October 24, 2012 and October 26, 2012, respectively, and websites www.bestbuyrx.com and www.drugworldcanada.com on January 8, 2013

2/4/13

Flu and Cold Defense LLC
(WARNING LETTER)

False and misleading statements; Internet marketing of product GermBullet on www.germbullet.com and www.nsaroma.com

1/24/13

Office of Drug Security, Integrity and Recalls 

Company/IndividualProduct/IssueIssue Date

BestCheapMedsOnline.com
WARNING LETTER

 

Internet Marketing of an Unapproved and Misbranded Drug7/15/13

Eva Pharmacy
(WARNING LETTER)

 

Internet Marketing of Unapproved and Misbranded Drugs
6/26/13
Internet Marketing of Unapproved and Misbranded Drugs
2/11/13
Internet Marketing of Unapproved and Misbranded Drugs
2/11/13
Internet Marketing of Unapproved and Misbranded Drugs
2/11/13
Internet Marketing of Unapproved and Misbranded Drugs
2/11/13
Internet Marketing of an Unapproved and Misbranded Drug
2/4/13
Internet Marketing of an Unapproved and Misbranded Drug
2/4/13

Office of Manufacturing and Product Quality

Company/IndividualProduct/IssueIssue Date
Wockhardt Limited
(WARNING LETTER)
regulations for finished pharmaceuticals11/25/13
Agila Specialties Private Limited
(WARNING LETTER)
regulations for finished pharmaceuticals9/9/13
Jabones Pardo S.A.
(WARNING LETTER)
regulations for finished pharmaceuticals8/22/13

Sentiss Pharma Pvt. Ltd. (Formerly Promed Exports Private Limited)(WARNING LETTER)

regulations for finished pharmaceuticals8/9/13
Posh Chemicals Pvt. Ltd.
(WARNING LETTER)
 
manufacture of APIs8/2/13
Aarti Drugs Limited
(WARNING LETTER)
 
regulations for finished pharmaceuticals7/30/13
Wockhardt Limited
(WARNING LETTER)
 
regulations for finished pharmaceucticals7/18/13
Fresenius Kabi AG
(WARNING LETTER)
 
manufacture of APIs7/1/13
RPG Life Sciences Ltd. 
(WARNING LETTER)
 
regulations for finished pharmaceuticals5/28/13
Ebewe Pharma Ges MBH Nfg KG
(WARNING LETTER)
 
regulations for finished pharmaceuticals5/28/13
Hospira Healthcare India Pvt. Ltd.
(WARNING LETTER)
 
regulations for finished pharmaceuticals5/28/13
Contract Pharmaceutical Services of Australia Pty Ltd
(WARNING LETTER)
 
regulations for finished pharmaceuticals5/17/13
Boehringer Ingelheim Pharma GMBH & Co
(WARNING LETTER)
 
manufacture of APIs and the CGMP regulations for finished pharmaceuticals5/6/13
CMI Cosmetic Manufacturers, Inc.
(WARNING LETTER)
 
CGMP/failure to register and list4/25/13
Kanebo Cosmetics, Inc.
(WARNING LETTER)
 
regulations for finished pharmaceuticals4/1/13
regulations for finished pharmaceuticals3/27/13
regulations for finished pharmaceuticals3/25/13
manufacture of APIs3/22/13
Apotex, Inc.
(WARNING LETTER)
regulations for finished pharmaceuticals2/21/13
P.A. Benjamin Manufacturing Co., Ltd.
(WARNING LETTER)
regulations for finished pharmaceuticals1/29/13
regulations for finished pharmaceuticals2/20/13

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

St Vincent Hospital and Health Care Center (WARNING LETTER)

Institutional Review Board

11/27/13

Stanislaw R. Burzynski, M.D., Ph.D.   
(WARNING LETTER)

Clinical Investigator

12/3/13

Burzynski Research Institute
(WARNING LETTER)

 

Sponsor Investigation

12/3/13

Agnes Ubani, M.D.
(WARNING LETTER)

 

Clinical Investigator11/21/13
Sreedhar Samudrala, M.D.  
(WARNING LETTER)
Clinical Investigator11/19/13

Dimitri Sirakoff, D.O.
(WARNING LETTER)

 

Clinical Investigator

9/12/13

Omid Nassim, M.D.
(WARNING LETTER)

 

Clinical Investigator

9/3/13

Bernard H. Doft, M.D.
(WARNING LETTER)

 

Clinical Investigator

6/12/13

Henry A. Frazer, Pharm.D.
(WARNING LETTER)

Clinical Investigator

6/5/13

Jose Joseph-Vempilly, MD
(WARNING LETTER)

 

Clinical Investigator

5/14/13

Shionogi, Inc.
UNTITLED LETTER - PDF

 

failure to comply with a postmarketing requirement (PMR) for Rybix ODT (Rybix), under NDA 021693

5/10/13

Agnesian Healthcare IRB
(WARNING LETTER)

 

Institutional Review Board

3/25/13

Singing River Health System IRB
(WARNING LETTER)

 

Institutional Review Board

2/1/13

Page Last Updated: 09/03/2014
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