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U.S. Department of Health and Human Services

Drugs

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Warning Letters 2014

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

Institut Biochimique SA (IBSA)

NDA 021924 Tirosint (levothyroxine sodium) capsules, for oral use2/24/2014

Mission Pharmaceutical Company

NDA 021618 Tindamax (tinidazole) tablets for oral use1/24/2014

 

Office of Compliance/Immediate Office 

 

Company/IndividualProduct/IssueIssue Date
   

 

Office of Drug Security, Integrity and Recalls 

Company/IndividualProduct/IssueIssue Date
   

  

Office of Manufacturing and Product Quality

Company/IndividualProduct/IssueIssue Date
SmithKline Beecham (Cork) Ltd.
(WARNING LETTER)

 
manufacture of active pharmaceutical ingredients (APIs)3/18/2014
manufacture of active pharmaceutical ingredients (APIs)3/6/2014
manufacture of active pharmaceutical ingredients (APIs)2/27/2014
USV Limited
(WARNING LETTER)

 
Regulations for finished pharmaceuticals2/6/2014
Labeling/relabeling of active pharmaceutical ingredients (APIs)1/31/2014

  

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date