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 month to view the letters in Adobe Acrobat format.
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.
The letters are arranged in chronological order by month. Click on the month to
view the letters in Adobe Acrobat (PDF) format. Go here for further information about Adobe Acrobat and download instructions.
[2008] [2007]
[2006]
[2005]
[2004]
[2003]
[2002]
[2001]
[2000]
1999
[1998]
[1997] |
Product |
Company |
Division |
Released |
Posted |
January |
AcuTect (kit for the preparation of Technetium
Tc99m Apctide injection) |
Diatide, Inc. |
DDMAC |
1/5/1999 |
1/14/1999 |
Azopt (brinzolamide ophthalmic suspension) |
Alcon Laboratories |
DDMAC |
1/5/1999 |
1/11/1999 |
Evista (raloxifene HCl) |
Eli Lilly |
DDMAC |
1/12/1999 |
1/20/1999 |
Lescol (fluvastatin sodium) capsules-Warning
Letter |
Novartis |
DDMAC |
1/21/1999 |
1/21/1999 |
Lotrel (amlodipine beslylate/benzepril HCl)
capsules |
Novartis |
DDMAC |
1/19/1999 |
1/26/1999 |
Nasonex (mometasone furoate monohydrate) Nasal
Spray |
Schering Corporation |
DDMAC |
1/5/1999 |
1/11/1999 |
Nolvadex (tamoxifen citrate) |
Zeneca |
DDMAC |
1/22/1999 |
2/17/1999 |
Novocol Pharmaceutical Site Inspection
(Warning Letter) |
Novocol Pharmaceutical |
DMPQ |
1/8/1999 |
1/13/1999 |
Oratest |
Zila, Inc. |
DDMAC |
1/28/1999 |
2/12/1999 |
Pramlintide |
Amylin Pharmaceuticals |
DDMAC |
1/21/1999 |
2/25/1999 |
Premarin (conjugated estrogens tablets) |
Wyeth-Ayerst |
DDMAC |
1/11/1999 |
1/14/1999 |
Preven Emergency Contraceptive Kit |
Gynetics Inc. |
DDMAC |
1/21/1999 |
1/26/1999 |
Prograf (tacrolimus) capsules |
Fujisawa USA |
DDMAC |
1/4/1999 |
1/11/1999 |
Remeron (mitrazapine) tablets |
Organon |
DDMAC |
1/5/1999 |
1/14/1999 |
Risperdal (risperidone) tablets and oral solution |
Janssen Research |
DDMAC |
1/5/1999 |
1/14/1999 |
Trivora, Zovia, Necon, Levora, Nor-QD Tablets |
Watson Laboratories |
DDMAC |
1/26/1999 |
2/12/1999 |
February |
Arava (leflunomide) tablets |
Hoechst Marion Roussel |
DDMAC |
2/23/1999 |
3/1/1999 |
Betoptic S (betaxolol HCl) Sterile Ophthalmic
Suspension |
Alcon Laboratories |
DDMAC |
2/23/1999 |
3/1/1999 |
Chirocaine (levobupivacaine) injection |
Parexel International Corporation |
DDMAC |
2/12/1999 |
5/18/1999 |
Coreg (carvedilol) tablets |
SmithKline Beecham |
DDMAC |
2/9/1999 |
4/13/1999 |
Deviation from compliance with Postmarketing
Adverse Experience reporting |
Schering AG |
DPDCS |
2/25/1999 |
3/12/1999 |
Ditropan (oxybutynin chloride) tablets |
Alza Corporation |
DDMAC |
2/12/1999 |
4/13/1999 |
Levoxyl (levothryoxine sodium) tablets, USP |
Jones Medical Industries |
DDMAC |
2/1/1999 |
2/12/1999 |
Valstar (valrubicin) |
Anthra Pharmaceuticals |
DDMAC |
2/16/1999 |
4/13/1999 |
Valtrex (valacyclovir HCl) caplets |
Glaxo Wellcome |
DDMAC |
2/1/1999 |
2/12/1999 |
March |
Avapro (irbesartan) tablets |
Bristol-Myers |
DDMAC |
3/31/1999 |
4/14/1999 |
Diprivan (propofol) injectable emulsion |
Zeneca Pharmaceuticals |
DDMAC |
3/23/1999 |
4/14/1999 |
Lamisil (terbinafine HCl) tablets |
Novartis |
DDMAC |
3/5/1999 |
4/14/1999 |
Migranal (dihydroergotamine mesylate) Nasal
Spray |
Novartis |
DDMAC |
3/1/1999 |
4/14/1999 |
Neoral (Cyclosporine) capsules and oral
solution |
Novartis |
DDMAC |
3/11/1999 |
4/14/1999 |
Prohance (gadoteridol) injection |
Bracco Diagnostics |
DDMAC |
3/31/1999 |
4/14/1999 |
SonoRx (simethicone coated cellulose
suspension) |
Bracco Diagnostics |
DDMAC |
3/31/1999 |
4/14/1999 |
Trovan (trovafloxacin/alatrofloxacin)
tablets/injection |
Pfizer |
DDMAC |
3/5/1999 |
4/14/1999 |
Xopenex (levalbuterol HCl) inhalation
solution |
Sepracor |
DDMAC |
3/26/1999 |
4/14/1999 |
Zofran (Ondansetron Hydrochloride)
Injection |
GlaxoWellcome |
DDMAC |
3/9/1999 |
3/29/1999 |
April |
Abarelix-Depot |
Amgen, Inc. |
DDMAC |
4/1/1999 |
5/18/1999 |
Alphagan (brimonidine tartrate) ophthalmic
solution |
Allergan |
DDMAC |
4/15/1999 |
5/18/1999 |
Avandia (rosiglitazone maleate) tablets |
SmithKline Beecham Pharmaceuticals |
DDMAC |
4/28/1999 |
5/18/1999 |
Cardura (doxazosin mesylate) tablets |
Pfizer |
DDMAC |
4/2/1999 |
4/14/1999 |
Ciloxan (ciprofloxacin HCl) |
Alcon Laboratories |
DDMAC |
4/15/1999 |
5/18/1999 |
Cipro (ciprofloxacin) tablets |
Bayer Pharm. |
DDMAC |
4/2/1999 |
4/14/1999 |
ClinCon Monitoring Inspection |
ClinCon Research Inc. |
DSI |
4/9/1999 |
5/21/1999 |
Combivir Tablets |
Glaxo Wellcome |
DDMAC |
4/23/1999 |
5/18/1999 |
Detrol (tolterodine tartrate) tablets |
Pharmacia & Upjohn |
DDMAC |
4/13/1999 |
5/18/1999 |
Ditropan XL (oxybutynin chloride) tablets |
Alza Corporation |
DDMAC |
4/2/1999 |
4/14/1999 |
Livostin (levocabastine HCl) ophthalmic
suspension |
Ciba Vision |
DDMAC |
4/6/1999 |
4/14/1999 |
Lovenox (enoxaparin sodium) injection |
Rhone-Poulenc Rorer |
DDMAC |
4/8/1999 |
6/8/1999 |
Magnevist (gadopentetate dimeglumine) injection |
Berlex Laboratories |
DDMAC |
4/15/1999 |
5/18/1999 |
MD-Gastroview (diatrizoate meglumine and
diatrizoate sodium solution) |
Mallinckrodt |
DDMAC |
4/15/1999 |
5/18/1999 |
Micardis (telmisartan) tablets |
Boehringer Ingelheim |
DDMAC |
4/16/1999 |
5/18/1999 |
MiraLax (polyethylene glycol 3350, NF
Powder) |
Braintree Laboratories |
DDMAC |
4/1/1999 |
4/14/1999 |
Serostim (somatropin) for injection |
Serono Laboratories |
DDMAC |
4/27/1999 |
5/18/1999 |
Suprane (desflurane, USP) |
Baxter Pharmaceutical Products |
DDMAC |
4/19/1999 |
5/18/1999 |
TobraDex (tobramycin and dexamethsone) sterile
ophthalmic suspension |
Alcon |
DDMAC |
4/16/1999 |
5/18/1999 |
Zemuron (recuronium bromide) |
Organon |
DDMAC |
4/19/1999 |
5/18/1999 |
May |
Bioresearch Monitoring Program Inspection-Warning
Letter |
Bruce Ettinger, M.D. |
DSI |
5/19/1999 |
7/8/1999 |
Bioresearch Monitoring Program-Warning
Letter |
Research Across America |
DSI |
5/25/1999 |
10/1/1999 |
Bioresearch Monitoring Program Inspection-Warning
Letter |
Rush-Presbyterian-St. Luke's Medical Center |
DSI |
5/19/1999 |
6/8/1999 |
Embeline E (clobetasol propianate cream
emollient) |
Healthpoint |
DDMAC |
5/20/1999 |
5/24/1999 |
Ergomar Sublingual Tablets (ergotamine tartate) |
Lotus Biochemical Corporation |
DDMAC |
5/14/1999 |
6/1/1999 |
Estrostep (norethindrone acetate and ethinyl
estradiol) tablets |
Parke-Davis |
DDMAC |
5/5/1999 |
5/18/1999 |
Inspection |
Harvard Scientific Corp |
DSI |
5/18/1999 |
6/8/1999 |
Leustatin (cladribine) |
R.W. Johnson Pharmaceuticals Research Institutue |
DDMAC |
5/10/1999 |
5/19/1999 |
Prilosec (omeprazole) plus Biaxin |
Astra Pharmaceuticals |
DDMAC |
5/21/1999 |
5/24/1999 |
Rhinocort (budesonide) nasal inhaler |
Astra Pharmaceuticals |
DDMAC |
5/5/1999 |
5/18/1999 |
Seroquel (quetiapine fumarate) tablets |
Zeneca Pharmaceuticals |
DDMAC |
5/6/1999 |
5/18/1999 |
Site Inspection-Warning Letter |
Eli Lilly Italia S.p.A. |
DMPQ |
5/28/1999 |
6/8/1999 |
Xopenex (levalbuterol HCl) inhalation solution |
Sepracor Inc. |
DDMAC |
5/21/1999 |
6/1/1999 |
June |
Agenerase (amprenavir) |
Glaxo Wellcome |
DDMAC |
6/4/1999 |
6/9/1999 |
Avandia (rosiglitazone maleate) tablets |
SmithKline Beecham |
DDMAC |
6/29/1999 |
7/1/1999 |
Lipitor (atrovastatin calcium) tablets |
Parke-Davis |
DDMAC |
6/22/1999 |
6/29/1999 |
Navelbine (vinorelbine) for injection |
Glaxo Wellcome |
DDMAC |
6/21/1999 |
8/6/1999 |
Site Inspection-Warning Letter |
Solvay Pharmaceuticals |
DMPQ |
6/23/1999 |
7/2/1999 |
Vanceril 42 mcg (beclomethasone dipropionate)
inhalation aerosol |
Schering Corporation |
DDMAC |
6/14/1999 |
6/21/1999 |
July |
Adefovir dipivoxil |
Gilead Sciences |
DDMAC |
7/16/1999 |
12/20/1999 |
Carnitor (levocarnitine) |
Sigma-Tau Pharmaceuticals |
DDMAC |
7/15/1999 |
8/12/1999 |
Crixivan (indinavir sulfate) tablets |
Merck |
DDMAC |
7/2/1999 |
7/8/1999 |
Fosamax (alendronate sodium) and Vioxx
(rofecoxib) |
Merck |
DDMAC |
7/16/1999 |
8/12/1999 |
Rebetron Combination Therapy |
Schering Corporation |
DDMAC |
7/15/1999 |
2/29/2000 |
Site Inspection-Warning Letter |
PharmaKinetics |
DSI |
7/27/1999 |
8/20/1999 |
Tapazole (methimazole) |
Eli Lilly and Company |
DDMAC |
7/2/1999 |
7/8/1999 |
Xenical (orlistat tetrahydrolipstatin) |
Hoffman-La Roche |
DDMAC |
7/19/1999 |
8/12/1999 |
August |
Flonase (fluticasone propionate) nasal spray |
Glaxo Wellcome |
DDMAC |
8/18/1999 |
12/20/1999 |
Liquid Deprenyl Citrate-Warning
Letter |
Discovery Experimental |
DLNDC |
8/16/1999 |
8/20/1999 |
Phoslo (calcium acetate) tablets |
Braintree Laboratories |
DDMAC |
8/1/1999 |
9/27/1999 |
September |
Anadrol-50 (oxymetholone) tablets-Warning
Letter |
Unimed Pharmaceuticals, Inc. |
DDMAC |
9/1/1999 |
9/9/1999 |
Arimidex (anastrozole) tablets |
Zeneca Pharmaceuticals |
DDMAC |
9/27/1999 |
10/26/1999 |
Bactroban Nasal (calcium mupirocin) |
SmithKline Beecham |
DDMAC |
9/9/1999 |
9/27/1999 |
Camptosar Injection (irinotecan HCL) |
Pharmacia and Upjohn |
DDMAC |
9/9/1999 |
9/27/1999 |
Cleocin Vaginal Ovules (clindamycin
phosphate) vaginal suppository |
Pharmacia and Upjohn |
DDMAC |
9/22/1999 |
12/20/1999 |
Diovan (valsartan) capsules |
Novartis |
DDMAC |
9/23/1999 |
10/4/1999 |
Flonase (fluticasone propionate) nasal spray |
GlaxoWellcome |
DDMAC |
9/17/1999 |
12/20/1999 |
GBC-590 |
SafeScience |
DDMAC |
9/10/1999 |
2/29/2000 |
Ipratropium Bromide Inhalation Solution-Warning
Letter |
Dey Laboratories |
DDMAC |
9/1/1999 |
9/9/1999 |
Lescol (fluvastatin sodium) capsules |
Novartis |
DDMAC |
9/22/1999 |
10/4/1999 |
Plendil (felodipine) extended-release tablets |
AstraZeneca |
DDMAC |
9/23/1999 |
10/6/1999 |
Site inspection-Warning Letter |
Long March Pharmaceuticals |
DMPQ |
9/7/1999 |
10/1/1999 |
Site inspection-Warning Letter |
Specialties Septodont |
DMPQ |
9/24/1999 |
12/20/1999 |
October |
Arthrotec (diclofenac Na/misoprostol) tablets |
G.D. Searle |
DDMAC |
10/13/1999 |
12/15/1999 |
Atacand (candesartan cilextil) tablets |
AstraZeneca |
DDMAC |
10/28/1999 |
12/15/1999 |
Baycol (cerivastatin sodium) |
Bayer |
DDMAc |
10/25/1999 |
12/15/1999 |
Brevibloc (esmolol hydrochloride) injection |
Baxter |
DDMAC |
10/1/1999 |
12/15/1999 |
Celebrex (celecoxib) capsules |
G.D. Searle |
DDMAC |
10/6/1999 |
12/15/1999 |
Claritin (loratadine) tablets |
Schering Corporation |
DDMAC |
10/8/1999 |
12/15/1999 |
Cytomel (liothyronine sodium) tablets |
Joes Pharma Incorporated |
DDMAC |
10/28/1999 |
12/15/1999 |
EpiPen and EpiPen Jr. (epinephrine
auto-injector) |
Dey Laboratories |
DDMAC |
10/6/1999 |
12/15/1999 |
Hydrea (hydroxyurea) capsules and Droxia
(hydroxyurea) capsules-Warning Letter |
Bristol-Myers Squibb |
DDMAC |
10/27/1999 |
11/9/1999 |
Xenical (orlistat) capsules |
Hoffman-La Roche |
DDMAC |
10/6/1999 |
10/26/1999 |
November |
Adenoscan (adenosine) |
Fujisawa Healtchare |
DDMAC |
11/29/1999 |
2/29/2000 |
Aloprim (allopurinol sodium) for injection |
Nabi |
DDMAC |
11/2/1999 |
12/15/1999 |
Astelin (azelastine HCl) Nasal Spray |
Carter-Wallace |
DDMAC |
11/12/1999 |
12/15/1999 |
Flovent (fluticasone propionate) inhalation
aerosol |
Glaxo Wellcome |
DDMAC |
11/30/1999 |
2/2/2000 |
Lidoderm (lidocaine patch 5%) |
Endo Pharmaceuticals |
DDMAC |
11/24/1999 |
2/29/2000 |
MUSE (alprostadil) urethral suppository |
VIVUS |
DDMAC |
11/3/1999 |
12/15/1999 |
Relenza (zanamivir for inhalation) |
Glaxo Wellcome Inc. |
DDMAC |
11/23/1999 |
1/11/2000 |
Site Inspection-Warning Letter |
WIL Research Laboratories |
DSI |
11/26/1999 |
12/3/1999 |
Sporanox (itraconazole) capsules |
Janssen Pharmaceutica |
DDMAC |
11/9/1999 |
12/15/1999 |
Tambocor (flecainide acetate) tablets |
3M Pharmaceuticals |
DDMAC |
11/1/1999 |
12/15/1999 |
December |
Allegra (fexofenadine HCl) capsules |
Hoechst Marion Roussle |
DDMAC |
12/6/1999 |
2/29/2000 |
Avelox (moxifloxacin hydrochloride) tablets |
Bayer Corporation |
DDMAC |
12/15/1999 |
12/16/1999 |
Site Inspection-Warning Letter |
Coulston Foundation |
DSI |
12/22/1999 |
1/6/2000 |
Vioxx (rofecoxib) tablets |
Merck & Co |
DDMAC |
12/6/1999 |
2/29/2000 |
Zydone (hydrocodone bitartrate and
acetaminophen) tablets |
Endo Pharmaceuticals |
DDMAC |
12/1/1999 |
2/2/2000 |