FDA Recalls, Alerts, and Warnings
Welcome
to the FDA Recalls, Alerts, and Warnings page. Here you will find an
up-to-date list of drugs for which the Food and Drug Administration
(FDA) has issued a recall, alert, or warning. To read the accompanying
FDA press release on any drug listed below, simply click on the title
of the release.
This page was last updated on April 03, 2006
| Date |
Generic Name |
Trade Name |
Details |
| May 11, 2006 |
contact lens cleaning solution |
ReNu with MoistureLoc® |
 |
| May 2, 2006 |
acetaminophen |
Goldline ® brand Extra Strength Genapap 500mg caplets and tablets and Extra Strength Genebs 500mg caplets and tablets |
|
| March 17, 2006 |
mifepristone |
Mifeprex |
|
| March 9, 2006 |
dietary supplements |
Anabolic Xtreme Superdrol and Methyl-1-P |
|
| February 24, 2006 |
dietary supplements containing ephedrine alkaloids |
Lipodrene, Stimerex-ES and Betadrene |
|
| February 16, 2006 |
gatifloxacin |
Tequin |
|
| February 13, 2006 |
salt solution |
Balanced Salt Solution |
|
| February 8, 2006 |
aprotinin injection |
Trasylol |
|
| February 3, 2006 |
human cells, tissues, and cellular and tissue-based products |
none given |
|
| January 20, 2006 |
bogus flu products |
Warning about all bogus flu products, such as counterfeit Tamiflu. |
|
| January 19, 2006 |
pimecrolimus and tacrolimus |
Elidel Cream and Protopic Ointment |
|
| January 13, 2006 |
weight loss supplements |
Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement |
|
| January 12, 2006 |
dietary supplement containing ephedrine alkaloid |
Lipodrene |
|
| December 19, 2005 |
medical testing device |
NeutroSpec [Technetium (99m TC) Fanolesomab] |
|
| December 16, 2005 |
illegal prescription drugs imported into this country |
not identified |
|
| December 16, 2005 |
medical device |
Meridian Hemodialysis Instrument with model numbers 5M5576 and 5M5576R |
|
| December 13, 2005 |
bogus flu products |
Nature's
Biotics, Lingoji, Natural Cellular Defense, Immunity Plus, Immunocil™,
Vira 38, NSI GliSODin®, NSI Superior Ester-C with Quercetin and
Bioflavonoids; NSI Vitamin C; NSI Green Tea Extract, NSI Activated
Quercetin Complex, NSI Probiotic with Acidophilus, Rhamnosus,
Thermophilus and Bulgaricus, NSI AHCC+ Immune Power, NSI L-Optizinc and
ZymePro Plus™ w/Serrapeplase |
|
| December 6, 2005 |
herbal supplement |
Nature's Treat Energy Plus #1 |
|
| November 29, 2005 |
various eye drops |
Oxydrops,
Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and
Can-C, as well as several OTC pain relieving drugs - Biogesic, Bio-Ice
and Bio-Heat |
|
| October 26, 2005 |
human tissue - including bone, skin and tendons. |
none given |
|
| October 26, 2005 |
blood glucose meters |
FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra,
MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, Precision
Sof-Tact meters, and private label brands ReliOn Ultima, Rite Aid and
Kroger blood glucose meters |
|
| October 24, 2005 |
weight loss drugs |
various |
|
| October 17, 2005 |
flu vaccine |
various |
|
| October 14, 2005 |
infusion pumps |
SYNDEO PCA Syringe Pumps, Colleague Volumetric Infusion Pumps, and Colleague CX Volumetric Infusion Pumps, respectively |
|
| October 6, 2005 |
calibration sets |
VeriCal® Calibrator Sets |
|
| September 30, 2005 |
Pmeningococcal conjugate vaccine A, C, Y, and W135 |
Menactra |
|
| September 29, 2005 |
atomoxetine |
Strattera |
|
| September 15, 2005 |
Positron Emission Tomography (PET) drugs |
none |
|
| August 29, 2005 |
mouthwash and hygiene kits |
Medline brand alcohol-free mouthwash |
|
| August 12, 2005 |
isotretinoin |
Accutane, Amnesteemm, Claravis and Sotret |
|
| July 29, 2005 |
counterfeit atorvastin |
counterfeit "Lipitor" |
|
| July 27, 2005 |
Certain cough and cold liquids, tablets, and caplets |
none |
|
| July 21, 2005 |
intraveneous delivery system |
Colleague Volumetric Infusion Pumps |
|
| July 19, 2005 |
mifepristone and misoprostol |
Mifeprex, also known as RU-486, and Cytotec |
|
| July 15, 2005 |
transdermal fentanyl |
Duragesic |
|
| July 13, 2005 |
hydromorphone hydrochloride |
Palladone |
|
| July 8, 2005 |
tadalafil, vardenafil and sildenafil |
Cialis, Levitra and Viagra |
|
| July 1, 2005 |
dietary supplement |
Liqiang 4 dietary supplement capsules |
|
| June 24, 2005 |
Enclosed bed systems |
None |
|
| June 17, 2005 |
defibrillators and cardiac resynchronization therapy |
PRIZM
2 DR, Model 1861, manufactured on or before April 16, 2002, CONTAK
RENEWAL, Model H135, manufactured on or before August 26, 2004, CONTAK
RENEWAL 2, Model H155, manufactured on or before August 26, 2004 |
|
| June 3, 2005 |
Acetaminophen |
Children's
TYLENOL® Meltaways 80 mg packaged in bottles and blisters, Children's
TYLENOL® SoftChews 80mg packaged in blisters, and Junior TYLENOL®
Meltaways 160mg packaged in blisters. |
|
| May 27, 2005 |
manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) |
none |
|
| May 20, 2005 |
dextromethorphan |
Various |
|
| May 18, 2005 |
Over-the-counter supplement |
Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer |
|
| May 10, 2005 |
Counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" |
Counterfeit versions of medications to treat cholesterol and sexual problems |
|
| May 10, 2005 |
Automatic external defibrillators |
AED20 Automatic External Defibrillators |
|
| April 28, 2005 |
various |
various prescription drugs |
|
| April 28, 2005 |
paroxetine HCI |
Paxil |
|
| April 11, 2005 |
aripiprazole, olanzapine, quetiapine, risperidone, clozapine and ziprasidone, and olanzapine/fluoxetine. |
Abilify, Zyprexa, Seroquel, Risperdal, Clozaril, Geodon and Symbyax |
|
| April 7, 2005 |
valdecoxib, celecoxib |
Bextra, Celebrex |
|
| March 31, 2005 |
Albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants |
None |
|
| March 22, 2005 |
enclosed bed systems |
Vail 500, 1000 and 2000 Enclosed Bed Systems |
|
| March 18, 2005 |
magnesium sulfate solution |
PharMEDium Services magnesium sulfate 1 gram in 50mL D5W (piggyback) IV solution |
|
| March 10, 2005 |
pimecrolimus and tacrolimus |
Elidel and Protopic |
|
| March 4, 2005 |
paroxetine hydrochloride and rosiglitazone maleate, and metformin hydrochloride |
Paxil CR and Avandamet tablets |
|
| March 2, 2005 |
rosuvastatin calcium |
Crestor |
|
| February 28, 2005 |
nataluzimab |
Tysabri |
|
| February 25, 2005 |
ephedrine alkaloids |
SciFit Procuts and Thermogen |
|
| February 7, 2005 |
Home-use test kits |
Rapid
HIV Test Kit, Rapid Syphilis Test Kit, One Step Cassette Style Cocaine
Test, One Step Cassette Style Marijuana Test, One Step Cassette Style
Amphetamine Test, Rapid Dengue Fever Test and One Step Midstream Style
HCG Urine (Home), Pregnancy Test |
|
| January 31, 2005 |
Preloaded syringe |
None |
|
| December 27, 2004 |
gabapentin and itraconazole |
Neurontin and Sporanox |
|
| December 20, 2004 |
naproxen |
Various |
|
| December 17, 2004 |
gefitinib |
Iressa |
|
| December 17, 2004 |
atomoxetine |
Straterra |
|
| December 17, 2004 |
celecoxib |
Celebrex |
|
| December 16, 2004 |
ginseng |
Ginseng |
|
| December 9, 2004 |
valdecoxib |
Bextra |
|
| December 8, 2004 |
lithium carbonate |
Carbolith |
|
| December 1, 2004 |
Two drugs: penicillin G benzathine/penicillin G procaine injectable suspension and penicillin G benzathine injectable suspension |
Bicillin CR and Bicillin LA |
|
| November 23, 2004 |
ephedra-containing supplement |
VITERA-XT |
|
| November 17, 2004 |
medroxyprogesterone |
Depo-Provera Contraceptive Injection |
|
| November 15, 2004 |
mifepriston |
Mifeprex, also known as RU-486 |
|
| November 2, 2004 |
Supplements |
Actra-Rx and Yilishen |
|
| September 30, 2004 |
rofecoxib |
Vioxx |
|
| September 24, 2004 |
Cochlear implant hearing aids |
CLARION and HiResolution cochlear implants |
|
| August 23, 2004 |
Mammograms |
None |
|
NOTE: Click on the to read the details of the recall.
| Date |
: |
May 11, 2006 |
| Generic Name |
: |
contact lens cleaning solution |
| Trade Name |
: |
ReNu with MoistureLoc® |
| Manufacturer |
: |
Bausch & Lomb |
| Type of Drug/Product |
: |
contact lens cleaning solution |
| FDA Release |
: |
Bausch
& Lomb has proposed that unique characteristics of the formulation
of the ReNu with MoistureLoc product in certain unusual circumstances
can increase the risk of Fusarium infection. Based on this scientific
and epidemiological data suggesting that ReNu with MoistureLoc may
increase susceptibility to Fusarium, Bausch & Lomb has decided to
permanently remove the ReNu with MoistureLoc product worldwide. FDA
supports this decision. To date, data available do not indicate a
problem with ReNu MultiPlus or ReNu Multi-Purpose or generic brands of
this contact lens cleaning solution. |
| Date |
: |
May 2, 2006 |
| Generic Name |
: |
acetaminophen |
| Trade Name |
: |
Goldline ® brand Extra Strength Genapap 500mg caplets and tablets and Extra Strength Genebs 500mg caplets and tablets |
| Manufacturer |
: |
IVAX Pharmaceuticals, Inc. |
| Type of Drug/Product |
: |
pain reliever |
| FDA Release |
: |
The product lots listed in the press release are being recalled because
of a labeling error. Specifically, the product label should indicate
that usage should not exceed 8 tablets or caplets in a 24 hour period.
The erroneous label indicates not to exceed 12 tablets or caplets in a
24 hour period. In the event the maximum dosage of 8 tablets or caplets
in a 24 hour period is exceeded, there may be an increased risk of
acetaminophen toxicity to the liver, which may cause adverse health
effects. |
| Date |
: |
March 17, 2006 |
| Generic Name |
: |
mifepristone |
| Trade Name |
: |
Mifeprex |
| Manufacturer |
: |
Danco Laboratories |
| Type of Drug/Product |
: |
induces medical abortion |
| FDA Release |
: |
The
FDA has been informed of two additional deaths following medical
abortion with Mifeprex. The FDA is investigating these cases is not
able to confirm the causes of death. |
| Date |
: |
March 9, 2006 |
| Generic Name |
: |
dietary supplements |
| Trade Name |
: |
Anabolic Xtreme Superdrol and Methyl-1-P |
| Manufacturer |
: |
Anabolic
Resources LLC, Gilbert, Arizona, and distributed by Supplements To Go,
Cincinnati, Ohio (Anabolic Xtreme Superdrol); and Legal Gear, Brighton,
MI and distributed by Affordable Supplements, Wichita, Kansas
(Methyl-1-P) |
| Type of Drug/Product |
: |
dietary supplements meant to increase strength |
| FDA Release |
: |
The
FDA warned several manufacturers and distributors of unapproved drugs
containing steroids that continuing to sell these products without FDA
approval could mean these products will be seized. The FDA is concerned
that these products, which are marketed as dietary supplements and
promoted for building muscle and increasing strength, may damage the
liver, cause male infertility, raise the risk of heart attack and
stroke, and stunt growth in children. |
| Date |
: |
February 24, 2006 |
| Generic Name |
: |
dietary supplements containing ephedrine alkaloids |
| Trade Name |
: |
Lipodrene, Stimerex-ES and Betadrene |
| Manufacturer |
: |
Hi-Tech Pharmaceuticals |
| Type of Drug/Product |
: |
dietary supplements |
| FDA Release |
: |
The U.S. Marshals Service began seizing these dietary supplements and
ingredients located at Hi-Tech's facilities in Norcross, GA. Through
this action, the FDA, in conjunction with the Department of Justice,
prevented about $3 million worth of products from reaching consumers
and endangering their health. |
| Date |
: |
February 16, 2006 |
| Generic Name |
: |
gatifloxacin |
| Trade Name |
: |
Tequin |
| Manufacturer |
: |
Bristol-Myers Squibb Co. |
| Type of Drug/Product |
: |
an antibiotic to treat pneumonia, bronchitis, uncomplicated gonorrhea
and various infections, including infections of the urinary tract,
kidneys and skin |
| FDA Release |
: |
Bristol-Myers Squibb Co. announced labeling changes for Tequin because
of continued reports of serious cases of low and high blood sugar. |
| Date |
: |
February 13, 2006 |
| Generic Name |
: |
salt solution |
| Trade Name |
: |
Balanced Salt Solution |
| Manufacturer |
: |
Cytosol Laboratories, Inc., of Braintree, Mass. |
| Type of Drug/Product |
: |
A drug used to irrigate a patient's eyes, ears, nose and/or throat during surgical procedures, such as cataract surgery |
| FDA Release |
: |
The FDA delivered a letter to the company to ask for a recall of all
brands and sizes of Balanced Salt Solution that the firm makes. The FDA
has received reports of a serious and potentially irreversible eye
injury called toxic anterior segment syndrome. |
| Date |
: |
February 8, 2006 |
| Generic Name |
: |
aprotinin injection |
| Trade Name |
: |
Trasylol |
| Manufacturer |
: |
Bayer |
| Type of Drug/Product |
: |
A drug used to prevent blood loss during surgery |
| FDA Release |
: |
The FDA is alerting doctors who do heart bypass surgery and patients
that Trasylol has been linked in two scientific publications to higher
risks of serious side effects, including kidney problems, heart attacks
and strokes in patients who undergo artery bypass graft surgery. |
| Date |
: |
February 3, 2006 |
| Generic Name |
: |
human cells, tissues, and cellular and tissue-based products |
| Trade Name |
: |
none given |
| Manufacturer |
: |
Biomedical Tissue Services, Ltd. of Fort Lee, N.J. |
| Type of Drug/Product |
: |
human cells, tissues, and cellular and tissue-based products |
| FDA Release |
: |
The FDA ordered Biomedical Tissue Services to immediately stop making
all tissue products initially recovered from human donors by the
company. The FDA is concerned that problems it has found in the
manufacturing process may endanger public health. |
| Date |
: |
January 20, 2006 |
| Generic Name |
: |
bogus flu products |
| Trade Name |
: |
Warning about all bogus flu products, such as counterfeit Tamiflu. |
| Manufacturer |
: |
various |
| Type of Drug/Product |
: |
bogus flu products |
| FDA Release |
: |
The FDA warns consumers not to buy bogus flu products. Consumers should
be aware that there are no approved vaccines for preventing avian flu
in people and no drugs have been approved for treating avian flu
symptoms. These products may endanger consumers' health because they
are not overseen by the FDA and/or may not work. |
| Date |
: |
January 19, 2006 |
| Generic Name |
: |
pimecrolimus and tacrolimus |
| Trade Name |
: |
Elidel Cream and Protopic Ointment |
| Manufacturer |
: |
Novartis manufactures Elidel cream; Astellas Pharma, Inc (formerly Fujisawa Healthcare) manufactures Protopic ointment |
| Type of Drug/Product |
: |
topical eczema drugs |
| FDA Release |
: |
The FDA announced the approval of updated labeling for Elidel Cream and
Protopic Ointment. Rare reports of cancer, such as skin and lymphoma,
have been associated with use, although a link has not been proven. |
| Date |
: |
January 13, 2006 |
| Generic Name |
: |
weight loss supplements |
| Trade Name |
: |
Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement |
| Manufacturer |
: |
Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim |
| Type of Drug/Product |
: |
weight loss dietary supplement |
| FDA Release |
: |
The FDA warns consumers not to use two unapproved drugs being marketed
as weight loss dietary supplements. These drugs may contain ingredients
found in prescription drugs - chlordiazepoxide HCl (the active
ingredient in Librium®), and fluoxetine HCl (the active ingredient in
Prozac®). Librium can be addictive and is used to treat symptoms of
alcohol withdrawal. Prozac is used to treat depression. |
| Date |
: |
January 12, 2006 |
| Generic Name |
: |
dietary supplement containing ephedrine alkaloid |
| Trade Name |
: |
Lipodrene |
| Manufacturer |
: |
ATF Fitness Products, Inc., Oakmont, PA. |
| Type of Drug/Product |
: |
dietary supplement containing ephedrine alkaloid |
| FDA Release |
: |
The
U.S. Marshals seized Lipodrene, which contains a daily dose of 50 mg of
ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants
that can be dangerous for the heart. |
| Date |
: |
December 19, 2005 |
| Generic Name |
: |
medical testing device |
| Trade Name |
: |
NeutroSpec [Technetium (99m TC) Fanolesomab] |
| Manufacturer |
: |
Palatin Technologies Inc. and marketing partner, Mallinckrodt |
| Type of Drug/Product |
: |
A device to diagnose appendicitis |
| FDA Release |
: |
The
FDA issued a Public Health Advisory to alert health care providers that
the agency has requested the market withdrawal of the diagnostic
imaging agent NeutroSpec pending further review of reported deaths and
serious and life-threatening events associated with the product. The
manufacturer and its marketing partner have agreed to an immediate
voluntary market suspension. |
| Date |
: |
December 16, 2005 |
| Generic Name |
: |
illegal prescription drugs imported into this country |
| Trade Name |
: |
not identified |
| Manufacturer |
: |
not identified |
| Type of Drug/Product |
: |
Illegal prescription drugs imported into this country. |
| FDA Release |
: |
An
FDA operation found that nearly half of the imported drugs FDA
intercepted from four selected countries were shipped to fill orders
that consumers believed they were placing with "Canadian" pharmacies.
Of the drugs being promoted as "Canadian," based on accompanying
documentation, 85 percent actually came from 27 countries around the
globe. A number of these products were also found to be counterfeit. |
| Date |
: |
December 16, 2005 |
| Generic Name |
: |
medical device |
| Trade Name |
: |
Meridian Hemodialysis Instrument with model numbers 5M5576 and 5M5576R |
| Manufacturer |
: |
Baxter Healthcare |
| Type of Drug/Product |
: |
A device that prepares dialysis solution and circulates blood through an external tubing system
Manufacturer: Baxter Healthcare Corporation of Deerfield, Ill |
| FDA Release |
: |
The
FDA announced that Baxter Healthcare has initiated a worldwide recall
of its Meridian Hemodialysis Instrument because of reports of hemolysis
(red blood cell destruction) that can result in kidney damage, anemia
and other serious health problems. The hemolysis is caused by kinking
in the blood tubing sets used with the Meridian. This has contributed
to one death and one serious injury. |
| Date |
: |
December 13, 2005 |
| Generic Name |
: |
bogus flu products |
| Trade Name |
: |
Nature's
Biotics, Lingoji, Natural Cellular Defense, Immunity Plus, Immunocil™,
Vira 38, NSI GliSODin®, NSI Superior Ester-C with Quercetin and
Bioflavonoids; NSI Vitamin C; NSI Green Tea Extract, NSI Activated
Quercetin Complex, NSI Probiotic with Acidophilus, Rhamnosus,
Thermophilus and Bulgaricus, NSI AHCC+ Immune Power, NSI L-Optizinc and
ZymePro Plus™ w/Serrapeplase |
| Manufacturer |
: |
Sacred
Mountain Management Inc, BODeSTORE.com, Melvin Williams, Iceland
Health, Inc., PolyCil Health Inc., PRB Pharmaceuticals, Chozyo, LLC,
Vitacost.com, Inc and Healthworks 2000 |
| Type of Drug/Product |
: |
Several bogus flu products |
| FDA Release |
: |
The
FDA issued warning letters to nine companies marketing bogus flu
products. These companies claim their products could help prevent the
avian flu or other forms of the flu. The FDA is not aware of any
evidence that shows that these are safe and do what the label claims.
The agency is concerned that the use of these products could harm
consumers or interfere with standard medical treatments. |
| Date |
: |
December 6, 2005 |
| Generic Name |
: |
herbal supplement |
| Trade Name |
: |
Nature's Treat Energy Plus #1 |
| Manufacturer |
: |
Nature's Treat, Inc., Gainesville, Texas and ACD Distributing, LLC, of Eugene, Oregon |
| Type of Drug/Product |
: |
Herbal supplement |
| FDA Release |
: |
At
the request of the FDA, the U.S. Attorney's Office for the Eastern
District of Texas and the U.S. Attorney's Office for the District of
Oregon filed Complaints for Forfeiture against Nature's Treat Energy
Plus #1, a dietary supplement that contains ephedra, an herbal source
of ephedrine alkaloids. This substance can have potentially dangerous
effects on the heart. |
| Date |
: |
November 29, 2005 |
| Generic Name |
: |
various eye drops |
| Trade Name |
: |
Oxydrops,
Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and
Can-C, as well as several OTC pain relieving drugs - Biogesic, Bio-Ice
and Bio-Heat |
| Manufacturer |
: |
MBI Distributing, Inc., also known as Molecular Biologics |
| Type of Drug/Product |
: |
Over-the-counter medications |
| FDA Release |
: |
The
FDA announced that MBI Distributing, Inc. has signed a consent decree
that requires it to stop manufacturing and distributing drugs until it
corrects manufacturing deficiencies and other violations at its
Benicia, California facility. The FDA also determined that two of the
firm's eye drop brands, Visitein and Clarity Vision for Life, are
unapproved drugs. In addition, Biogesic, Bio-Ice and Bio-Heat do not
provide adequate warnings for their safe use. |
| Date |
: |
October 26, 2005 |
| Generic Name |
: |
human tissue - including bone, skin and tendons. |
| Trade Name |
: |
none given |
| Manufacturer |
: |
Biomedical Tissue Services, Ltd. of Ft. Lee, NJ |
| Type of Drug/Product |
: |
Human tissue |
| FDA Release |
: |
The
FDA is notifying the public of its investigation of human tissue
recovered by Biomedical Tissue Services, Ltd. and sent to tissue
processors. Some of this tissue may have been implanted into patients
from early 2004 to September 2005. The tissue was recovered by BTS from
human donors who may not have met FDA donor eligibility requirements
and who may not have been properly screened for certain infectious
diseases. |
| Date |
: |
October 26, 2005 |
| Generic Name |
: |
blood glucose meters |
| Trade Name |
: |
FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra,
MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, Precision
Sof-Tact meters, and private label brands ReliOn Ultima, Rite Aid and
Kroger blood glucose meters |
| Manufacturer |
: |
Abbott Diabetes Care, Alameda, California |
| Type of Drug/Product |
: |
Treatment of diabetes |
| FDA Release |
: |
The FDA is alerting patients about a problem with blood glucose meters
made by Abbott Diabetes Care. The meters can unintentionally be
switched from one unit of measurement to another, resulting in an
inaccurate blood glucose reading by the user. An inaccurate reading can
lead to taking the wrong dose of insulin or to dietary changes,
resulting in higher levels of blood sugar or hyperglycemia. |
| Date |
: |
October 24, 2005 |
| Generic Name |
: |
weight loss drugs |
| Trade Name |
: |
various |
| Manufacturer |
: |
Unknown |
| Type of Drug/Product |
: |
Bogus weight loss drugs |
| FDA Release |
: |
Under a Trilateral Cooperation Charter agreement between Mexico, the
United States and Canada signed in 2003, six agencies (two from each
country) announced that they have taken nearly 730 compliance actions
against companies that promote bogus weight loss products that mislead
the public, endanger the public health, provide false hope and defraud
citizens of billions of dollars. |
| Date |
: |
October 17, 2005 |
| Generic Name |
: |
flu vaccine |
| Trade Name |
: |
various |
| Manufacturer |
: |
Sanofi Pasteur, Inc., MedImmune Vaccines, Inc., GlaxoSmithKline Biologicals and Chiron |
| Type of Drug/Product |
: |
Prevention of the flu |
| FDA Release |
: |
The FDA anticipates the production of more vaccine than last year. At
this time, the FDA does not know the exact number of doses to be
distributed, but despite Chiron's lowered projections announced on
October 17, the FDA still expects that there will be significantly more
vaccine produced than last year. |
| Date |
: |
October 14, 2005 |
| Generic Name |
: |
infusion pumps |
| Trade Name |
: |
SYNDEO PCA Syringe Pumps, Colleague Volumetric Infusion Pumps, and Colleague CX Volumetric Infusion Pumps, respectively |
| Manufacturer |
: |
Baxter Healthcare Corporation |
| Type of Drug/Product |
: |
Provide controlled delivery of solutions and medications to patients. |
| FDA Release |
: |
The
U.S. District Court for the Northern District of Illinois issued a
warrant for seizure of three types of infusion pumps made by Baxter
Healthcare Corporation because FDA inspections revealed that the firm
has continually failed to follow medical device manufacturing
requirements. Pump shutdown could result in serious injuries or death
to critically ill patients who depend on continuous infusion
medications and/or life-sustaining medications. |
| Date |
: |
October 6, 2005 |
| Generic Name |
: |
calibration sets |
| Trade Name |
: |
VeriCal® Calibrator Sets |
| Manufacturer |
: |
BioMerieux, Inc., Durham, North Carolina |
| Type of Drug/Product |
: |
These sets calibrate laboratory tests that are used to monitor a patient's anticoagulation therapy. |
| FDA Release |
: |
BioMerieux has issued a worldwide voluntary correction recall of
VeriCal Calibrator Sets because they are mislabeled and could result in
misdiagnosis or injury to patients; serious illness or death from
erroneous calibration data leading to use of improper levels of oral
anticoagulant drugs. |
| Date |
: |
September 30, 2005 |
| Generic Name |
: |
Pmeningococcal conjugate vaccine A, C, Y, and W135 |
| Trade Name |
: |
Menactra |
| Manufacturer |
: |
Sanofi Pasteur |
| Type of Drug/Product |
: |
Protects against meningococcal infection, a major cause of bacterial meningitis. |
| FDA Release |
: |
The
FDA and Centers for Disease Control and Prevention are alerting
consumers and health care providers to five reports of guillain barre
syndrome (GBS) following administration of meningococcal conjugate
vaccine A, C, Y, and W135. It is not known yet whether these cases were
caused by the vaccine or are coincidental. GBS is a serious
neurological disorder that can occur, often in healthy people, either
spontaneously or after certain infections. GBS typically causes
increasing weakness in the legs and arms that can be severe and can
require hospitalization. |
| Date |
: |
September 29, 2005 |
| Generic Name |
: |
atomoxetine |
| Trade Name |
: |
Strattera |
| Manufacturer |
: |
Eli Lily and Company |
| Type of Drug/Product |
: |
Treatment of attention deficit disorder |
| FDA Release |
: |
The
FDA issued a Public Health Advisory to alert doctors that Straterra may
be associated with suicidal thinking in children and teens. Children
and teens should be closely watched for agitation, irritability,
suicidal thinking or behaviors, and unusual changes in behavior,
especially during the first few months of therapy or when the dose is
changed. |
| Date |
: |
September 15, 2005 |
| Generic Name |
: |
Positron Emission Tomography (PET) drugs |
| Trade Name |
: |
none |
| Manufacturer |
: |
Various |
| Type of Drug/Product |
: |
PET is a medical diagnostic tool in which a radioactive drug is administered to a patient. |
| FDA Release |
: |
The
FDA announced a proposed current good manufacturing practices
regulation for the production of positron emission tomography (PET)
drugs. The regulation, which establishes minimum standards for the
production and testing of PET drug products, is intended to ensure that
PET drug products meet the requirements of the Federal Food, Drug, and
Cosmetic Act as to safety, identity, strength, quality and purity. |
| Date |
: |
August 29, 2005 |
| Generic Name |
: |
mouthwash and hygiene kits |
| Trade Name |
: |
Medline brand alcohol-free mouthwash |
| Manufacturer |
: |
Medline Industries, Inc., Mundelein, Ill |
| Type of Drug/Product |
: |
Mouthwash |
| FDA Release |
: |
The
FDA has notified the public of a nationwide voluntary recall of
alcohol-free mouthwash and hygiene kits containing mouthwash
distributed by Medline Industries because of potential contamination
with Burkholderia cepacia. Consumers and health care providers who have
Medline brand alcohol-free mouthwash should stop using the product
immediately and check to see if it is being recalled. |
| Date |
: |
August 12, 2005 |
| Generic Name |
: |
isotretinoin |
| Trade Name |
: |
Accutane, Amnesteemm, Claravis and Sotret |
| Manufacturer |
: |
Roche Pharmaceuticals Inc, Mylan Pharmaceuticals Inc., Barr Laboratories, Inc., Ranbaxy Laboratories, Inc |
| Type of Drug/Product |
: |
Treatment of severe acne |
| FDA Release |
: |
The FDA approved a strengthened distribution program for isotretinoin,
called iPLEDGE, aimed at preventing use of the drug during pregnancy.
Women who are pregnant or who might become pregnant should not take the
drug because of a high risk of birth defects. |
| Date |
: |
July 29, 2005 |
| Generic Name |
: |
counterfeit atorvastin |
| Trade Name |
: |
counterfeit "Lipitor" |
| Manufacturer |
: |
none |
| Type of Drug/Product |
: |
Treatment of high cholesterol |
| FDA Release |
: |
The FDA is alerting Americans about a recent recall of a batch of
counterfeit Lipitor sold in the United Kingdom (U.K.). Health
authorities in the U.K. said the initial results of tests done on the
counterfeits do not indicate that this product poses an immediate risk
to patients, however, they are advising that patients stop taking the
drug and return it to the pharmacy where they got it. The affected
product is the 20 mg strength. "Lipitor" is sold in packages of 28
tablets. The drug packages are marked with batch number 004405K1 and an
expiration date of "11 2007." |
| Date |
: |
July 27, 2005 |
| Generic Name |
: |
Certain cough and cold liquids, tablets, and caplets |
| Trade Name |
: |
none |
| Manufacturer |
: |
Pharmakon Labs, Inc. |
| Type of Drug/Product |
: |
Cough and cold liquids, tablets and caplets |
| FDA Release |
: |
The
FDA announced it was shutting down operations at Pharmakon Labs of
Florida. Following inspections by the FDA and a trial in U.S. District
Court, Judge Richard A. Lazzara found that drug products sold by
Pharmakon Labs, Inc., its president Abelardo L. Acebo, and its
secretary/treasurer Edward R. Jackson did not meet current good
manufacturing practice standards and other legal requirements. |
| Date |
: |
July 21, 2005 |
| Generic Name |
: |
intraveneous delivery system |
| Trade Name |
: |
Colleague Volumetric Infusion Pumps |
| Manufacturer |
: |
Baxter Healthcare Corporation |
| Type of Drug/Product |
: |
Intraveneous delivery system |
| FDA Release |
: |
The
FDA is announcing that Baxter Healthcare Corporation is recalling all
models of its Colleague Volumetric Infusion Pumps because they can shut
down while delivering critical medication and fluids to patients. |
| Date |
: |
July 19, 2005 |
| Generic Name |
: |
mifepristone and misoprostol |
| Trade Name |
: |
Mifeprex, also known as RU-486, and Cytotec |
| Manufacturer |
: |
Danco Laboratories |
| Type of Drug/Product |
: |
Used in abortion procedures |
| FDA Release |
: |
The FDA is issuing a public health advisory about the risk of blood
infection when undergoing medical abortion using these two drugs in a
manner that is not consistent with the approved labeling. There are now
four cases of deaths from infection from September 2003 to June 2005
following medical abortion. |
| Date |
: |
July 15, 2005 |
| Generic Name |
: |
transdermal fentanyl |
| Trade Name |
: |
Duragesic |
| Manufacturer |
: |
Janssen Pharmaceuticals |
| Type of Drug/Product |
: |
potent narcotic medication for pain |
| FDA Release |
: |
The
FDA issued an advisory about the safe use of transdermal fentanyl
patches in response to reports of death in people using this medication
for pain management. |
| Date |
: |
July 13, 2005 |
| Generic Name |
: |
hydromorphone hydrochloride |
| Trade Name |
: |
Palladone |
| Manufacturer |
: |
Purdue Pharma L.P. |
| Type of Drug/Product |
: |
Once-a-day pain management drug containing a very potent narcotic |
| FDA Release |
: |
The
drug may cause serious and even deadly reactions when taken with
alcohol. The FDA asked its maker to withdraw the medication. |
| Date |
: |
July 8, 2005 |
| Generic Name |
: |
tadalafil, vardenafil and sildenafil |
| Trade Name |
: |
Cialis, Levitra and Viagra |
| Manufacturer |
: |
Bayer Pharmaceuticals |
| Type of Drug/Product |
: |
Treatment for erectile dysfunction |
| FDA Release |
: |
The
FDA approved updated labeling for Cialis, Levitra and Viagra to reflect
a small number of post-marketing reports of sudden vision loss. |
| Date |
: |
July 1, 2005 |
| Generic Name |
: |
dietary supplement |
| Trade Name |
: |
Liqiang 4 dietary supplement capsules |
| Manufacturer |
: |
Liqiang
Research Institute, China, and marketed throughout the United States in
herbal stores and through mail order by Bugle International of
Northridge, CA. |
| Type of Drug/Product |
: |
Dietary supplement |
| FDA Release |
: |
The
FDA is warning consumers not to take Liqiang 4 dietary supplement
capsules because they contain glyburide - a drug that could have
serious, life-threatening consequences in some people. Glyburide is a
drug used to lower blood sugar, and is safe and effective when used as
labeled in FDA-approved medications. People who have low blood sugar or
those with diabetes can receive dangerously high amounts of glyburide
by consuming Liqiang 4. |
| Date |
: |
June 24, 2005 |
| Generic Name |
: |
Enclosed bed systems |
| Trade Name |
: |
None |
| Manufacturer |
: |
Vail Products, Inc. |
| Type of Drug/Product |
: |
5,000 "enclosed" bed systems |
| FDA Release |
: |
The FDA is notifying consumers that Vail Products is initiating a
nationwide recall of about 5,000 "enclosed" bed systems. The Vail
Products enclosed bed systems have caused entrapment of some people
using the bed, resulting in severe brain damage or death because they
couldn't breath. The company has sent new instruction manuals and
warning labels to every customer informing them of the FDA's advice to
stop using the bed system, move patients to other beds systems if
possible and talk to their doctor. |
| Date |
: |
June 17, 2005 |
| Generic Name |
: |
defibrillators and cardiac resynchronization therapy |
| Trade Name |
: |
PRIZM
2 DR, Model 1861, manufactured on or before April 16, 2002, CONTAK
RENEWAL, Model H135, manufactured on or before August 26, 2004, CONTAK
RENEWAL 2, Model H155, manufactured on or before August 26, 2004 |
| Manufacturer |
: |
Guidant Corporation |
| Type of Drug/Product |
: |
Implantable devices that treat heart conditions |
| FDA Release |
: |
FDA
is notifying health care providers and patients that the Guidant
Corporation is recalling certain implantable defibrillators and cardiac
resynchronization therapy defibrillators. These devices can develop an
internal short circuit without warning, resulting in failure to deliver
a shock when needed. |
| Date |
: |
June 3, 2005 |
| Generic Name |
: |
Acetaminophen |
| Trade Name |
: |
Children's
TYLENOL® Meltaways 80 mg packaged in bottles and blisters, Children's
TYLENOL® SoftChews 80mg packaged in blisters, and Junior TYLENOL®
Meltaways 160mg packaged in blisters. |
| Manufacturer |
: |
McNeil Consumer & Specialty Pharmaceuticals |
| Type of Drug/Product |
: |
Pain reliever |
| FDA Release |
: |
All
lots and all flavors of Children's TYLENOL® Meltaways 80 mg packaged in
bottles and blisters, Children's TYLENOL® SoftChews 80mg packaged in
blisters, and Junior TYLENOL® Meltaways 160mg packaged in blisters have
been recalled voluntarily by the manufacturer. The blister package
design, as well as the information on the blister package and on the
blister and bottle cartons may be confusing and could lead to improper
dosing, including over-dosing. |
| Date |
: |
May 27, 2005 |
| Generic Name |
: |
manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) |
| Trade Name |
: |
none |
| Manufacturer |
: |
Able Laboratories |
| Type of Drug/Product |
: |
manufactured drugs |
| FDA Release |
: |
The
FDA is taking action to ensure that the public is fully aware that Able
Laboratories of Cranbury, NJ, is conducting a nationwide recall of all
of its manufactured drugs (mostly generic prescription drugs, including
drugs containing acetaminophen) because of serious concerns that they
were not produced according to quality assurance standards. Able
Laboratories has ceased all current production. |
| Date |
: |
May 20, 2005 |
| Generic Name |
: |
dextromethorphan |
| Trade Name |
: |
Various |
| Manufacturer |
: |
Various |
| Type of Drug/Product |
: |
Found in over-the-counter cough and cold remedies |
| FDA Release |
: |
The FDA is concerned about the abuse of dextromethorphan (DXM), found
in many over-the-counter cough and cold medicines. The agency warns of
potential harm, after five recently reported deaths of teens that may
be related to powdered DXM sold in capsules. Although DXM in small
amounts is safely used in cough suppressants, abuse of the drug can
cause death, brain damage, seizure, loss of consciousness and irregular
heartbeat. DXM abuse is a trend involving the sale of pure DXM in
powdered form on the street. |
| Date |
: |
May 18, 2005 |
| Generic Name |
: |
Over-the-counter supplement |
| Trade Name |
: |
Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer |
| Manufacturer |
: |
The Master's Miracle |
| Type of Drug/Product |
: |
Supplement that manufacturer says treats cataracts (clouding of the eye's lens and allergy symptoms of the eye). |
| FDA Release |
: |
The
Master's Miracle (TMM) company is alerting the public against applying
the company's TMM brand Fortified Mineral Neutralizer and Ultra
Fortified Mineral Neutralizer to the eyes because these products may be
contaminated with Pseudomonas aeruginosa, Pseudomonas flourescens/putida and Enterobacter cloacae -- bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. |
| Date |
: |
May 10, 2005 |
| Generic Name |
: |
Counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" |
| Trade Name |
: |
Counterfeit versions of medications to treat cholesterol and sexual problems |
| Manufacturer |
: |
Sold by Mexican pharmacies |
| Type of Drug/Product |
: |
Illegal products to treat cholesterol and sexual problems, respectively. |
| FDA Release |
: |
The FDA is warning the public about the sale of counterfeit versions of
Lipitor, Viagra and an unapproved product promoted as "generic Evista"
to Americans at pharmacies in Mexican border towns. Do not use these
products. Counterfeit Lipitor that may not have any active ingredient
or not enough active ingredient could cause complications of high
cholesterol, such as heart disease. |
| Date |
: |
May 10, 2005 |
| Generic Name |
: |
Automatic external defibrillators |
| Trade Name |
: |
AED20 Automatic External Defibrillators |
| Manufacturer |
: |
MRL, Inc. |
| Type of Drug/Product |
: |
Treats ailing hearts |
| FDA Release |
: |
A voluntary recall was announced by manufacturer MLA for 597 automatic
external defibrillators made in Buffalo Grove, IL between February 2004
and July 2004. The AED20 may display a "Defib Comm" error message on
the device display during use leading to a failure of the device to
analyze the patient's ECG and deliver the right therapy, which keeps
the defibrillator from resuscitating a patient. |
| Date |
: |
April 28, 2005 |
| Generic Name |
: |
various |
| Trade Name |
: |
various prescription drugs |
| Manufacturer |
: |
PDRX,
also operating under the name of Pharma Discount in Salt Lake City,
Utah; Empire Pharmaceuticals in Newbury Park, Calif.; DRX Medical, also
operating under the name of Defonte Trading, in Aberdeen, N.J.; as well
as PRNY Enterprises, AC Global, AC Healthcare, and Afro Caribbean
Healthcare, all in Floral Park, N.Y. |
| Type of Drug/Product |
: |
Various prescription drugs, such as Viagra |
| FDA Release |
: |
The FDA announced indictments against several prescription drug
distributors whose illegal distribution of certain drugs could affect
the safety and effectiveness of more than 40 medications sold at more
than 80 pharmacies nationwide. Diverted drugs are medications illegally
bought, sold or otherwise circulated outside distribution systems that
assure the public of their quality. |
| Date |
: |
April 28, 2005 |
| Generic Name |
: |
paroxetine HCI |
| Trade Name |
: |
Paxil |
| Manufacturer |
: |
GlaxoSmithKline, Inc. |
| Type of Drug/Product |
: |
Treatment of depression and panic disorder |
| FDA Release |
: |
The FDA says GlaxoSmithKline, Inc. will fix manufacturing problems at
its Cidra, Puerto Rico plant. FDA's last inspection found Paxil CR
tablets could split apart, which could cause patients to receive a
portion of the tablets that does not have the active ingredient, or to
get a portion that has an active ingredient and does not have the
intended controlled-release effect. |
| Date |
: |
April 11, 2005 |
| Generic Name |
: |
aripiprazole, olanzapine, quetiapine, risperidone, clozapine and ziprasidone, and olanzapine/fluoxetine. |
| Trade Name |
: |
Abilify, Zyprexa, Seroquel, Risperdal, Clozaril, Geodon and Symbyax |
| Manufacturer |
: |
BristolMeyersSquibb Company, Eli Lilly and Company, Jannsen Pharmaceuticals, Novartis and Pfizer |
| Type of Drug/Product |
: |
Atypical antipsychotic drugs |
| FDA Release |
: |
The FDA issued a public health advisory to alert health care providers,
patients and patient caregivers to new safety information concerning an
unapproved (i.e., "off-label") use of atypical antipsychotic drugs.
These drugs are approved for the treatment of schizophrenia and mania,
but clinical studies of these drugs to treat behavioral disorders in
elderly patients with dementia have shown a higher death rate
associated with their use compared to patients receiving a sugar pill. |
| Date |
: |
April 7, 2005 |
| Generic Name |
: |
valdecoxib, celecoxib |
| Trade Name |
: |
Bextra, Celebrex |
| Manufacturer |
: |
Pfizer |
| Type of Drug/Product |
: |
Painkiller |
| FDA Release |
: |
The FDA asked Pfizer to withdraw Bextra from the market because the
overall risk-versus-benefit profile for the drug is unfavorable. The
FDA has also asked Pfizer to include a boxed warning on the Celebrex
label. Pfizer suspended sales and marketing of Bextra in the United
States pending further discussions with the agency. Pfizer has agreed
to work with FDA on the boxed warning for Celebrex. The FDA is asking
manufacturers of all other prescription NSAIDs to revise their labels
to include the same boxed warning highlighting the potential for
increased risk of cardiovascular events and gastrointestinal bleeding
associated with their use. |
| Date |
: |
March 31, 2005 |
| Generic Name |
: |
Albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants |
| Trade Name |
: |
None |
| Manufacturer |
: |
Various |
| Type of Drug/Product |
: |
Inhalers for treatment of asthma |
| FDA Release |
: |
The
FDA announced that albuterol metered-dose inhalers (MDIs) using
chlorofluorocarbon (CFC) propellants must no longer be produced,
marketed or sold in the United States after December 31, 2008. In a
final rule published in the March 31, 2005 Federal Register, Health and
Human Services said sufficient supplies of two approved,
environmentally friendly albuterol inhalers will exist by December 31,
2008 to allow the phasing out of similar less environmentally friendly
versions. |
| Date |
: |
March 22, 2005 |
| Generic Name |
: |
enclosed bed systems |
| Trade Name |
: |
Vail 500, 1000 and 2000 Enclosed Bed Systems |
| Manufacturer |
: |
Vail Products, Inc. |
| Type of Drug/Product |
: |
Enclosed bed systems |
| FDA Release |
: |
The
FDA and the Department of Justice starting seizing all finished Vail
500, 1000 and 2000 Enclosed Bed Systems. Use of these systems poses a
public health risk because patients can become entrapped and suffocate,
resulting in severe neurological damage or death. |
| Date |
: |
March 18, 2005 |
| Generic Name |
: |
magnesium sulfate solution |
| Trade Name |
: |
PharMEDium Services magnesium sulfate 1 gram in 50mL D5W (piggyback) IV solution |
| Manufacturer |
: |
PharMEDium Services |
| Type of Drug/Product |
: |
frequently administered intravenously to patients undergoing cardiac surgery |
| FDA Release |
: |
The FDA issued a nationwide alert against the use of PharMEDium
Services magnesium sulfate 1 gram in 50mL D5W (piggyback) IV solution,
lot number 100504900049, expiration date 4/4/05. This product may be
contaminated with Serratia marcescens bacteria that can cause serious,
life-threatening illness in patients with compromised immune systems. |
| Date |
: |
March 10, 2005 |
| Generic Name |
: |
pimecrolimus and tacrolimus |
| Trade Name |
: |
Elidel and Protopic |
| Manufacturer |
: |
Novartis |
| Type of Drug/Product |
: |
Treatment of eczema |
| FDA Release |
: |
The
FDA told health care professionals to prescribe Elidel and Protopic
only as directed and only after other eczema treatments have failed
because of a potential cancer risk associated with their use. Findings
of cancer in three different animal species were reviewed and showed
the risk of cancer increased as the dose increased. More research is
being done. |
| Date |
: |
March 4, 2005 |
| Generic Name |
: |
paroxetine hydrochloride and rosiglitazone maleate, and metformin hydrochloride |
| Trade Name |
: |
Paxil CR and Avandamet tablets |
| Manufacturer |
: |
GlaxoSmithKline, Inc. |
| Type of Drug/Product |
: |
For treatment of depression and panic disorder (Paxil CR) and type 2 diabetes (Avandamet) |
| FDA Release |
: |
The FDA and the Department of Justice seized Paxil CR and Avandamet
tablets because manufacturing practices failed to meet FDA standards
that ensure product safety, strength, quality and purity. The FDA is
not aware of any harm to consumers by the products subject to this
seizure and it does not believe that these products pose a significant
health hazard. The FDA urges patients who use these drugs to keep
taking them and to talk with their health care provider about possible
alternatives until the problems have been fixed. The FDA found that the
Paxil tablets could split apart and patients could receive a portion of
the tablets that does not have the active ingredient, or alternatively
a portion that contains the active ingredient and does not have the
intended controlled-release effect. Some Avandamet tablets did not have
an accurate dose of rosiglitazone, an active ingredient in this
product. |
| Date |
: |
March 2, 2005 |
| Generic Name |
: |
rosuvastatin calcium |
| Trade Name |
: |
Crestor |
| Manufacturer |
: |
Astra-Zeneca Pharmaceuticals |
| Type of Drug/Product |
: |
A cholesterol-lowering drug |
| FDA Release |
: |
The
FDA issued a public health advisory that includes information about the
risk of rhabdomyolysis (serious muscle damage) in patients taking
Crestor or other statin drugs. This is a well-known, rare adverse
effect of all statins. |
| Date |
: |
February 28, 2005 |
| Generic Name |
: |
nataluzimab |
| Trade Name |
: |
Tysabri |
| Manufacturer |
: |
Biogen Idec |
| Type of Drug/Product |
: |
Treatment for patients with relapsing forms of multiple sclerosis |
| FDA Release |
: |
The FDA issued a public health advisory to inform patients and health
care providers about the suspended marketing of Tysabri (nataluzimab)
while the agency and the manufacturer evaluate two serious adverse
events reported with its use. The FDA received a report of one death
and one possible case of progressive multifocal leukoencephalopathy, a
rare, serious, progressive neurologic disease with no known effective
treatment. |
| Date |
: |
February 25, 2005 |
| Generic Name |
: |
ephedrine alkaloids |
| Trade Name |
: |
SciFit Procuts and Thermogen |
| Manufacturer |
: |
ATF Fitness Products, Inc. |
| Type of Drug/Product |
: |
Dietary supplement |
| FDA Release |
: |
U.S.
Marshals seized adulterated and misbranded dietary supplement
containing ephedrine alkaloids. The products include SciFit Procut lots
18822, 16312, 16918, 16834, and 19023 and Thermogen II lot 18981 in an
assortment of cases and bottles. The FDA determined the products either
contained prohibited ephedrine alkaloids or claimed to contain
ephedrine or ephedrine alkaloids but did not. |
| Date |
: |
February 7, 2005 |
| Generic Name |
: |
Home-use test kits |
| Trade Name |
: |
Rapid
HIV Test Kit, Rapid Syphilis Test Kit, One Step Cassette Style Cocaine
Test, One Step Cassette Style Marijuana Test, One Step Cassette Style
Amphetamine Test, Rapid Dengue Fever Test and One Step Midstream Style
HCG Urine (Home), Pregnancy Test |
| Manufacturer |
: |
Globus Media, Montreal, Canada. |
| Type of Drug/Product |
: |
Home-use test kits |
| FDA Release |
: |
The
FDA warns consumers not to use unapproved home-use diagnostic test kits
that have been marketed nationwide over the Internet by Globus Media.
In fact, no home-use test kits intended for diagnosing, syphilis and
dengue fever are approved for sale in the U.S. |
| Date |
: |
January 31, 2005 |
| Generic Name |
: |
Preloaded syringe |
| Trade Name |
: |
None |
| Manufacturer |
: |
IV Flush, LLC |
| Type of Drug/Product |
: |
Preloaded syringes containing heparin or sodium chloride intravenous flushes |
| FDA Release |
: |
The
FDA is issuing a nationwide alert against the use of all lots of
preloaded syringes containing either heparin or sodium chloride
intravenous catheter flushes because these products have not received
proper clearance from the FDA and may be contaminated. |
| Date |
: |
December 27, 2004 |
| Generic Name |
: |
gabapentin and itraconazole |
| Trade Name |
: |
Neurontin and Sporanox |
| Manufacturer |
: |
Canada Care Drugs, Inc. (Canada Care) |
| Type of Drug/Product |
: |
Various |
| FDA Release |
: |
The
United States District Court for the Southern District of New York
issued a court order to stop Canada Care from importing into the United
States medications that are not FDA approved. Unapproved drugs are more
likely to be contaminated, counterfeit and ineffective. |
| Date |
: |
December 20, 2004 |
| Generic Name |
: |
naproxen |
| Trade Name |
: |
Various |
| Manufacturer |
: |
Various |
| Type of Drug/Product |
: |
Over-the-counter medicine to treat pain |
| FDA Release |
: |
The
FDA is working with the National Institutes of Health to review
research on naproxen after the National Institute on Aging stopped a
clinical trial studying non-steroidal anti-inflammatory drugs in people
at risk of developing Alzheimer's disease. There is some evidence from
this study that showed a higher risk of heart disease. The FDA warns
patients who are taking over-the-counter naproxen products to carefully
follow the instructions on the label. Do not take more than the
recommended doses for naproxen (220 mg twice daily) and do not take
naproxen for longer than 10 days unless your doctor tells you
otherwise. |
| Date |
: |
December 17, 2004 |
| Generic Name |
: |
gefitinib |
| Trade Name |
: |
Iressa |
| Manufacturer |
: |
AstraZeneca |
| Type of Drug/Product |
: |
Treatment of non-small cell lung cancer |
| FDA Release |
: |
The
FDA learned a large clinical trial comparing gefitinib with a sugar
pill in people with non-small cell lung cancer who had failed other
courses of cancer therapy did not live any longer because of this drug. |
| Date |
: |
December 17, 2004 |
| Generic Name |
: |
atomoxetine |
| Trade Name |
: |
Straterra |
| Manufacturer |
: |
Eli Lilly and Company |
| Type of Drug/Product |
: |
Treatment of attention deficit hyperactivity disorder |
| FDA Release |
: |
A
new warning for atomoxetine, a drug for attention deficit hyperactivity
disorder, is being updated with a bolded warning about the potential
for severe liver injury. This was because of two reports in a teenager
and an adult who had been treated with atomoxetine for several months,
both of whom recovered. |
| Date |
: |
December 17, 2004 |
| Generic Name |
: |
celecoxib |
| Trade Name |
: |
Celebrex |
| Manufacturer |
: |
Pfizer, Inc. |
| Type of Drug/Product |
: |
Treatment of arthritis |
| FDA Release |
: |
The
National Cancer Institute and Pfizer, Inc. stopped drug administration
in an ongoing clinical trial investigating a new use of celecoxib to
prevent colon polyps. The research showed there is a higher risk of
heart disease in people taking Celebrex. |
| Date |
: |
December 16, 2004 |
| Generic Name |
: |
ginseng |
| Trade Name |
: |
Ginseng |
| Manufacturer |
: |
FCC Products, Inc. |
| Type of Drug/Product |
: |
Supplement |
| FDA Release |
: |
At
the request of the FDA, the U.S. District Court for the District of New
Jersey issued a warrant for the seizure of imported ginseng, and held
for sale at FCC Products, Inc. The U.S. Marshals Service and the FDA
seized the ginseng. These products contain pesticide chemical residues
that are unsafe. |
| Date |
: |
December 9, 2004 |
| Generic Name |
: |
valdecoxib |
| Trade Name |
: |
Bextra |
| Manufacturer |
: |
Pfizer Inc. |
| Type of Drug/Product |
: |
COX-2 selective non-steroidal anti-inflammatory drug to treat arthritis |
| FDA Release |
: |
New
warnings have been placed in the Prescribing Information insert for
Bextra, warning about the risk of life-threatening skin reactions and
that it should not be used for people getting bypass surgery. |
| Date |
: |
December 8, 2004 |
| Generic Name |
: |
lithium carbonate |
| Trade Name |
: |
Carbolith |
| Manufacturer |
: |
Valeant Canada Limited |
| Type of Drug/Product |
: |
Treatment of manic-depressive illness |
| FDA Release |
: |
FDA
is warning consumers about Carbolith, a product that has not been
approved by the FDA but is being sold over the Internet. The company’s
recent testing led to the conclusion that the product may not deliver
enough of the drug to ensure effectiveness. The FDA says consumers
taking the drug could have lowered blood lithium levels, which could
worsen bipolar illness. |
| Date |
: |
December 1, 2004 |
| Generic Name |
: |
Two drugs: penicillin G benzathine/penicillin G procaine injectable suspension and penicillin G benzathine injectable suspension |
| Trade Name |
: |
Bicillin CR and Bicillin LA |
| Manufacturer |
: |
King Pharmaceuticals, Inc. |
| Type of Drug/Product |
: |
Antibacterial, systemic. |
| FDA Release |
: |
The
FDA announced important labeling changes regarding Bicillin CR and
Bicillin LA. These changes include a new boxed warning against
injecting the drugs and a warning for Bicillin CR explaining it doesn’t
treat syphilis. |
| Date |
: |
November 23, 2004 |
| Generic Name |
: |
ephedra-containing supplement |
| Trade Name |
: |
VITERA-XT |
| Manufacturer |
: |
Asia MedLabs, Inc. |
| Type of Drug/Product |
: |
Supplement to treat fevers, allergies and heart muscle ailments; also helps with heart disease. |
| FDA Release |
: |
The
FDA says VITERA-XT is an unapproved and misbranded drug that is
dangerous for the public. The FDA has started legal action against the
manufacturer for producing this product. |
| Date |
: |
November 17, 2004 |
| Generic Name |
: |
medroxyprogesterone |
| Trade Name |
: |
Depo-Provera Contraceptive Injection |
| Manufacturer |
: |
Pfizer |
| Type of Drug/Product |
: |
An established injectable drug approved for use in women to prevent pregnancy. |
| FDA Release |
: |
The
FDA announced that a "black box" warning, highlighting that prolonged
use may result in loss of bone density, will be added to the labeling
of Depo-Provera, an established injectable drug approved for use in
women for prevention of pregnancy. |
| Date |
: |
November 15, 2004 |
| Generic Name |
: |
mifepriston |
| Trade Name |
: |
Mifeprex, also known as RU-486 |
| Manufacturer |
: |
Danco Laboratories |
| Type of Drug/Product |
: |
Birth control |
| FDA Release |
: |
A
"black box" warning will be added to mifepristone mentioning the risk
of serious bacterial infections, sepsis, bleeding and death that may
occur following any termination of pregnancy, including the use of
mifepristone. |
| Date |
: |
November 2, 2004 |
| Generic Name |
: |
Supplements |
| Trade Name |
: |
Actra-Rx and Yilishen |
| Manufacturer |
: |
None given |
| Type of Drug/Product |
: |
Dietary supplement to treat erectile dysfunction |
| FDA Release |
: |
The
Food and Drug Administration warned consumers not to purchase or to
consume Actra-Rx or Yilishen, two products promoted and offered for
sale on Web sites as "dietary supplements" for treating erectile
dysfunction and enhancing sexual performance for men. These products in
fact contain an active prescription drug ingredient. FDA has also
issued an Import Alert instructing FDA field personnel to stop the
importation of "Actra-Rx" and "Yilishen." |
| Date |
: |
September 30, 2004 |
| Generic Name |
: |
rofecoxib |
| Trade Name |
: |
Vioxx |
| Manufacturer |
: |
Merck & Co. |
| Type of Drug/Product |
: |
Drug to manage arthritis pain |
| FDA Release |
: |
The
FDA is alerting the public about a voluntary recall from the marketer
of Vioxx (rofecoxib), a non-steroidal anti-inflammatory drug used for
management of arthritis. Merck is withdrawing Vioxx after a study was
stopped early when the company learned of an increased risk of serious
cardiovascular events, including heart attacks and strokes. The study
was being done in patients at risk of developing recurrent colon
polyps, or abnormal growths in the colon. Talk to your doctor before
stopping Vioxx. |
| Date |
: |
September 24, 2004 |
| Generic Name |
: |
Cochlear implant hearing aids |
| Trade Name |
: |
CLARION and HiResolution cochlear implants |
| Manufacturer |
: |
Advanced Bionics Corporation, a wholly owned subsidiary of Boston Scientific Corporation |
| Type of Drug/Product |
: |
Hearing aids |
| FDA Release |
: |
Advanced
Bionics Corporation is recalling its unimplanted CLARION and
HiResolution cochlear implants because some devices may malfunction as
a result of moisture. Cochlear implants help adults and children with
severe-to-profound hearing loss by conducting an electrical stimulation
of the auditory nerve. |
| Date |
: |
August 23, 2004 |
| Generic Name |
: |
Mammograms |
| Trade Name |
: |
None |
| Manufacturer |
: |
Ecumed Health Group facility in Hialeah, Fla. |
| Type of Drug/Product |
: |
Mammograms |
| FDA Release |
: |
The
FDA is alerting patients about possible problems associated with the
quality of mammograms performed at the Ecumed Health Group facility in
Hialeah, Fla. over recent years. Women affected by this alert are those
who had mammograms at this facility from January 7, 2001 to the
present. The FDA's review of a sample of mammography examinations done
by the Ecumed Health Group facility showed that the mammograms were of
poor quality and not reliable and the facility did not meet the
standards for clinical image quality as required by the FDA. |
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