Drugs
Warning Letters 2004
2004 Warning Letters and Untitled Letters to Pharmaceutical Companies
These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and 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. Click on the links in each month to view the letters in Adobe Acrobat format. [more...]
December 2004
November 2004
October 2004
September 2004
August 2004
June 2004
Product/Issue | Company/Individual | Division | Released | Posted |
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Domperidone (Warning Letter) | Axium Healthcare Pharmacy | Compliance | 6/7/2004 | 6/7/2004 |
Domperidone (Warning Letter) | Drugs Are Us, Inc. DBA Hopewell Pharmacy | Compliance | 6/7/2004 | 6/7/2004 |
Domperidone (Warning Letter) | Peoples Pharmacy, Inc. | Compliance | 6/7/2004 | 6/7/2004 |
Domperidone (Warning Letter) | Spectrum Chemicals & Laboratory Products | Compliance | 6/7/2004 | 6/7/2004 |
Domperidone | Line Avenue Pharmacy | Compliance | 6/7/2004 | 6/7/2004 |
Norvir (ritonavir capsules) (Warning Letter) | Abbot Laboratories | DDMAC | 6/10/2004 | 6/10/2004 |
Paxil CR (paroxetine HCl) | GlaxoSmithKline | DDMAC | 6/2004 | 6/10/2004 |
May 2004
Product/Issue | Company/Individual | Division | Released | Posted |
---|
MUSE (alprostadil) (Warning Letter) | VIVUS, Inc. | DDMAC | 5/25/2004 | 5/27/2004 |
Prograf. (tacrolimus) (Warning Letter) | Fujisawa Healthcare, Inc. | DDMAC | 5/7/2004 | 5/13/2004 |
April 2004
March 2004
Product/Issue | Company/Individual | Division | Released | Posted |
---|
Effexor, Effexor XR | Wyeth Pharmaceuticals | DDMAC | 3/18/2004 | 2/26/2004 |
February 2004
January 2004
Product/Issue | Company/Individual | Division | Released | Posted |
---|
API Site Inspection (Warning Letter) | Delta Synthetic Co. | Compliance | 1/5/2004 | 5/19/2004 |
API Site Inspection (Warning Letter) | Aliachem A.S. | Compliance | 1/15/2004 | 5/19/2004 |
Prescription Drug Importation (Warning Letter) | - Expedite-RX
- SPC Global Technologies, Ltd.
- Employer Health Options, Inc.
| Compliance | 1/22/2004 | 1/23/2004 |
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
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