Drugs

Warning Letters 2015

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/Individual

Product/Issue

Issue Date

 Duchesnay, Inc.

NDA 021876 DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use  

 8/7/2015

ECR Pharmaceuticals, a wholly owned subsidiary of Valeant Pharmaceuticals International

 

ANDA 077273 TussiCaps(hydrocodone polistirex and chlorpheniramine polistirex) Extended-release Capsules CII

7/27/2015

ASCEND Therapeutics US, LLC

EstroGel® 0.06% (estradiol gel) for topical use 

6/23/2015

Actavis Laboratories UT, Inc. (formerly Watson Laboratories, Inc.)

NDA 022206 RAPAFLO® (silodosin) Capsule for oral use

 

5/19/2015

Oak Pharmaceuticals, Inc.
 

 

ANDA 083246 Nembutal Sodium Solution (pentobarbital sodium injection, USP) CII

5/14/2015

Otsuka Pharmaceutical Development & Commercialization, Inc.

NDA 021436  ABILIFY (aripiprazole) Tablets

4/17/2015

Discovery Laboratories

NDA 021746 Surfaxin (lucinactant) Intratracheal Suspension

3/5/2015

Gary W. Small, MD
Semel Institute for Neuroscience & Human Behavior, UCLA
Taumark.com

(F-18) FDDNP

2/20/2015

Luitpold Pharmaceuticals, Inc.

NDA 203565 Injectafer (ferric carboxymaltose injection)

1/29/2015

 

Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

Vista Pharmaceuticals, Ltd. 
(WARNING LETTER)

Failure to pay GDUFA fees 

 6/22/2015

Sharon Bio-Medicine Limited 
(WARNING LETTER)

Failure to pay GDUFA fees 

 6/22/2015

Syntho Pharmaceuticals
(WARNING LETTER)

Failure to pay GDUFA fees

 6/22/2015

Wuxi Kaili Pharmaceutical Company
(WARNING LETTER)

Failure to pay GDUFA fees

 6/22/2015

RemedyRepack Inc.
(WARNING LETTER)

 

Colchicine Tablet (NDC 49349-061)

3/31/2015

Rebel Distributors Corp.
(WARNING LETTER)

 

Cimetidine 300 mg tablet (NDC 21695-531), Cimetidine 400 mg tablet (NDC 21695-532), Digoxin 0.125 mg tablet (NDC 21695-678) and Hydrocodone Barbiturate and Acetaminophen 10mg/ 500 mg tablet (NDC 21695-273)

3/15/2015

Iso-Tex Diagnostics, Inc
(WARNING LETTER)

Volumex (Albumin Iodinated I-131 Serum) 0.025 mCi/mL

3/2/2015

Hemp Oil Care
www.hempoilcare.com
(WARNING LETTER)

“Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops”

2/26/2015

Modern Herb Shop Inc.
www.modernherbshop.com
(WARNING LETTER)

“Bone Knitting Powder,” “Bu Zhong Yi Qi Wan | Central Chi Teapills,” “Burn Ointment | Ching Wan Hung Soothing Herbal Balm,” “Chuan Xin Lian,” “Huang Lian Su,” “San Huang San | Herbal Ice,” “Si Miao San Herb Extract Powder,” “Wu Yang Brand Pain Relieving Medicated Plaster,” “Yunnan Baiyao Capsules and Powder,” and “Zheng Gu Shui”

2/26/2015

Natural Organic Solutions
www.purecbd.net and www.etsy.com/shop/PureCBD
(WARNING LETTER)

 

“CBD Hemp Oil Treatment,” “Hemp CBD (Cannabidiol) Extract Capsules,” “CBD Extract Capsules Anti Anxiety Formula,” and “High CBD Healing Salve”

2/26/2015

Infiniti Creations, Inc.
www.curadermcream.com (redirected to: www.bec5creamdirect.com)
(WARNING LETTER) 

 

 “Curaderm BEC 5 Cream” and “Tamanu Oil”

 2/26/2015

 

Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Zhejiang Hisun Pharmaceutical Co., Ltd.
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)

12/31/2015

Cadila Healthcare Limited
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)/Finished Pharmaceuticals

12/23/2015

Sun Pharmaceuticals Industries Ltd.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

12/17/2015

Chan Yat Hing Medicine Factory
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

12/15/2015

Dr. Reddy's Laboratories Limited
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)/Finished Pharmaceuticals

11/5/2015

Sandoz Private Limited
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

10/22/2015

Unimark Remedies Ltd.
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)

9/28/2015

Jaychem Industries, Inc.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

9/4/2015

Pan Drugs Limited
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)

9/2/2015

Mylan Laboratories Limited
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

8/6/2015

Sipra Labs Limited
(WARNING LETTER)

regulations for testing finished pharmaceuticals and active pharmaceutical ingredients (APIs)

7/23/2015

Mahendra Chemicals 
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs) 

 7/13/2015

Attix Pharmaceuticals
(WARNING LETTER)

 

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

6/22/2015

VUAB Pharma a.s.
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 320-15-10

5/27/15 

Yunnan Hande Bio-Tech. Co. Ltd.
(WARNING LETTER)

 

manufacture of active pharmaceutical ingredients (APIs)

4/6/2015

Hospira S.p.A.
(WARNING LETTER)

regulations for finished pharmaceuticals

3/31/2015

Novacyl (Thailand) Ltd.
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

2/27/2015

Cadila Pharmaceuticals Limited
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

2/25/2015

Micro Labs Limited
(WARNING LETTER)

regulations for finished pharmaceuticals

1/9/2015

Apotex Research Private Limited
(WARNING LETTER)

 

regulations for finished pharmaceuticals

1/30/2015

 

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Gregory J. Tracey, M.D.
(WARNING LETTER)

Clinical Investigator

12/16/2015

Monmouth Medical Center IRB
(WARNING LETTER)

 

Institutional Review Board

11/10/2015

Heritage Pharmaceuticals, Inc.
(WARNING LETTER)

PADE

11/5/2015

Thomas S. Tooma, M.D.
(WARNING LETTER)

Clinical Investigator

11/2/2015

Bernard A. Michlin, M.D.
(WARNING LETTER)

 

Clinical Investigator

7/13/2015

Howard M. Gross, M.D.
(WARNING LETTER)

Clinical Investigator

6/29/15 

AB Science  
(WARNING LETTER)

Sponsor

6/16/15 

Binh Bui Nguyen, M.D.
(WARNING LETTER)

Clinical Investigator

5/4/2015

CXL-USA, LLC
(WARNING LETTER)

 

Sponsor

 4/1/2015

 

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

Rx Partners
(WARNING LETTER)

 

Unlawful Sale of Unapproved and Misbranded Drug Products to United States consumers over the Internet

6/8/2015

Meds India LTD
(WARNING LETTER)

 

Unlawful Sale of Unapproved and Misbranded Drug Products to United States consumers over the Internet

6/8/2015

 

 

 

 

Page Last Updated: 04/01/2016
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