FDA NEWS

McNeil Consumer Healthcare Over-The-Counter Products: Recall

2010-02-06T00:44:00.001-08:00

McNeil Consumer Healthcare Over-The-Counter Products: Recall
December 2009 recall expanded to multiple products.
Source: www.fda.gov

Nipro GlucoPro Insulin Syringes: Recall
Needles may become detached and remain in the skin.
Source: www.fda.gov

FDA Approves Xiaflex for Debilitating Hand Condition
The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.
Source: www.fda.gov

U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in Connection with Unlicensed Cosmetic Treatments
According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for wrinkle removal such as Botox and Restylane.
Source: www.fda.gov

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Source: www.fda.gov

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays

2010-02-04T12:39:00.001-08:00

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

Postes internationaux de la FDA: Améliorer la sécurité des aliments et des produits médicaux importés
La mutation des membres de son personnel dans certaines régions à l’étranger est un facteur majeur de sa stratégie pour intensifier la surveillance des aliments et des produits médicaux importés.
Source: www.fda.gov

Recalls and Safety Alerts: Caution on Powerheart and CardioVive Automated External Defibrillators

2010-02-02T22:54:00.001-08:00

Recalls and Safety Alerts: Caution on Powerheart and CardioVive Automated External Defibrillators
FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or a...
Source: www.accessdata.fda.gov

Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Source: www.fda.gov

Nzu, Traditional Remedy for Morning Sickness
Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
Source: www.fda.gov

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
[UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Source: www.fda.gov

ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall
Device may crack near the radiopaque marker band, potentially resulting in serious patient injury.
Source: www.fda.gov

Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Source: www.fda.gov

FDA Statement on the Investigation into the Salmonella Montevideo Outbreak

2010-02-01T22:03:00.001-08:00

FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: December 2009
FDA has issued recent safety alerts on these products.
Source: www.fda.gov

Warning on Body Building Products (video)
In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: October 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Negative Pressure Wound Devices Draw FDA Notice, Advice
FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy.
Source: www.fda.gov

Recalls and Safety Alerts: Preventing Anaphylactic-type Reactions with Dexferrum

2010-01-26T11:28:00.001-08:00

Recalls and Safety Alerts: Preventing Anaphylactic-type Reactions with Dexferrum
American Regent has issued new precautionary measures for preventing anaphylactic-type reactions when administering Dexferrum (iron dextran injection). An updated boxed warning for Dexferrum now says that a test dose should be administered befor...
Source: www.accessdata.fda.gov

FDA, WebMD Expand Health Information Partnership

2010-01-25T20:52:00.001-08:00

FDA, WebMD Expand Health Information Partnership
FDA and WebMD have expanded their unique partnership to provide increased access to FDA’s consumer health information.
Source: www.fda.gov

Thermoflect Blankets and product line - Recall
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Source: www.fda.gov

FDA Unveils Safe Use Initiative to Reduce Harm From Medication Use
A new program aims to reduce unnecessary injuries from medication misuse, errors, and other problems.
Source: www.fda.gov

FDA to Examine the Safety of Caffeinated Alcoholic Beverages
Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Source: www.fda.gov

The Word is Out on Unapproved H1N1 Products
FDA has stepped up its campaign to inform consumers of—and protect them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the H1N1 flu virus.
Source: www.fda.gov

Warning on Body Building Products (video)
In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Source: www.fda.gov

Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness
Source: www.fda.gov

FDA's MedWatch Safety Alerts: November 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Recalls and Safety Alerts: Energy Levels in External Biphasic Defibrillators

2010-01-24T22:03:00.001-08:00

Recalls and Safety Alerts: Energy Levels in External Biphasic Defibrillators
FDA is looking into the safety and effectiveness of biphasic defibrillators used for cardioversion and defibrillation in order to understand the conditions that affect their performance. Over the past three years, FDA has received reports of 14 ...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Serious Complications with Negative Pressure Wound Therapy
FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from...
Source: www.accessdata.fda.gov

U.S. Attorney News Release: Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical Devices
Spectranetics Corporation, a medical device manufacturer, located in Colorado Springs, Colorado, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced today.
Source: www.fda.gov

FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.
Source: www.fda.gov

FDA Ends Maryland Seafood Processor’s Pattern of Sanitary Violations
The FDA today announced that a Maryland seafood processor delivering fresh, frozen, and ready-to-eat seafood in Virginia, Pennsylvania, and New Jersey, and Washington, D.C., is to stop processing and distributing adulterated fish and seafood because it is not compliant with federal food safety laws.
Source: www.fda.gov

FDA Warns Consumers about Counterfeit Alli
The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.
Source: www.fda.gov

FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and Distributed by Merrick Pet Care
The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of “Best By 111911” because the product may be contaminated with Salmonella.
Source: www.fda.gov

FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.
Source: www.fda.gov

Thermoflect Blankets and product line - Recall

2010-01-21T23:30:00.001-08:00

Thermoflect Blankets and product line - Recall
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Source: www.fda.gov

McNeil Consumer Healthcare Over-The-Counter Products: Recall
December 2009 recall expanded to multiple products.
Source: www.fda.gov

MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall
Dietary supplements recalled due to undeclared steroids in products, posing risk of acute liver injury.
Source: www.fda.gov

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.
Source: www.fda.gov

FDA Ends Maryland Seafood Processor’s Pattern of Sanitary Violations
The FDA today announced that a Maryland seafood processor delivering fresh, frozen, and ready-to-eat seafood in Virginia, Pennsylvania, and New Jersey, and Washington, D.C., is to stop processing and distributing adulterated fish and seafood because it is not compliant with federal food safety laws.
Source: www.fda.gov

Health Fraud Awareness (video)

2010-01-21T00:39:00.001-08:00

Health Fraud Awareness (video)
Learn how to spot health fraud and avoid it with this FDA Consumer Update video.
Source: www.fda.gov

Nzu, Traditional Remedy for Morning Sickness
Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
Source: www.fda.gov

Nzu, Traditional Remedy for Morning Sickness

2010-01-19T23:43:00.001-08:00

Nzu, Traditional Remedy for Morning Sickness
Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
Source: www.fda.gov

FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 & Stage 2 Baby Foods
The FDA is recommending that the public not consume any varieties of HAPPYTOT Stage 4 and certain varieties of HAPPYBABY Stage 1 and Stage 2 baby foods in pouches distributed by Nurture Inc. The firm is recalling these products because some pouches are leaking or swollen. Swollen or leaking pouches may indicate problems with the product, including possible contamination by bacteria that can cause illness, or that the packaging has been compromised and is at risk of bacterial contamination.
Source: www.fda.gov

Recalls and Safety Alerts: Warning Against Nebulizing Relenza Inhalation Powder
GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophyl...
Source: www.accessdata.fda.gov

Thermoflect Blankets and product line - Recall
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Source: www.fda.gov

Recalls and Safety Alerts: Nationwide Recall of AccuSure Insulin Syringes
Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay i...
Source: www.accessdata.fda.gov

Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter

2010-01-18T13:52:00.001-08:00

Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter
Risk of sudden death and cardiac dysrhythmias in patients being treated with Norpramin.
Source: www.fda.gov

Rapamune (sirolimus): Drug Monitoring Recommendations
Switching between assays for the same patient can produce differing results that may be clinically significant.
Source: www.fda.gov

Thermoflect Blankets and product line - Recall
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Source: www.fda.gov

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
[UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Source: www.fda.gov

Recalls and Safety Alerts: Emergency Use of Peramivir to Treat H1N1
FDA has authorized the emergency use of the investigational antiviral drug peramivir for certain adults and children hospitalized with confirmed or suspected 2009 H1N1 influenza. This includes patients who have an influenza A virus that is non-subty...
Source: www.accessdata.fda.gov

Steris System 1 Processor: FDA Notice and Recommendations
[UPDATED 12/17/2009] List of alternative products added. Unapproved device with potential for improper sterilization and disinfection.
Source: www.fda.gov

Recalls and Safety Alerts: Energy Levels in External Biphasic Defibrillators
FDA is looking into the safety and effectiveness of biphasic defibrillators used for cardioversion and defibrillation in order to understand the conditions that affect their performance. Over the past three years, FDA has received reports of 14 ...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Nationwide Recall of AccuSure Insulin Syringes
Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay i...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Recall of Liquid Glucose Hexokinase Reagent
Pointe Scientific has recalled certain lots of its Liquid Glucose Hexokinase Reagent. These reagents have failed to produce accurate results at glucose values above 200 mg/dL. A list of the affected lot numbers can be found below. The company is i...
Source: www.accessdata.fda.gov

CT Brain Perfusion Scans Safety Investigation: Initial Notification
[UPDATED 12/07/2009] FDA identified at least 50 additional patients exposed to excess radiation; interim recommendations for imaging facilities provided.
Source: www.fda.gov

FDA Approves New Drug for Rheumatoid Arthritis

2010-01-16T22:05:00.001-08:00

FDA Approves New Drug for Rheumatoid Arthritis
The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.
Source: www.fda.gov

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.
Source: www.fda.gov

FDA to Examine the Safety of Caffeinated Alcoholic Beverages
Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Source: www.fda.gov

LASIK: Quality of Life Project, Warning Letters to Facilities
On October 15, 2009, the U.S. Food and Drug Administration (FDA) launched a study of the impact of LASIK on patients' quality of life, and issued warning letters to 17 LASIK surgery centers that release patients the same day as their surgery.
Source: www.fda.gov

Consejos de seguridad de los alimentos para unas fiestas saludables
Los consumidores tienen una función que cumplir, sobre todo cuando manipulan los alimentos en el hogar.
Source: www.fda.gov

FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.
Source: www.fda.gov

Texas Department of State Health Services Issues Warning Against "Nzu" Products
Texas Department of State Health Services Issues Warning Against "Nzu" Products
Source: www.fda.gov

Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness
Source: www.fda.gov

FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 & Stage 2 Baby Foods
The FDA is recommending that the public not consume any varieties of HAPPYTOT Stage 4 and certain varieties of HAPPYBABY Stage 1 and Stage 2 baby foods in pouches distributed by Nurture Inc. The firm is recalling these products because some pouches are leaking or swollen. Swollen or leaking pouches may indicate problems with the product, including possible contamination by bacteria that can cause illness, or that the packaging has been compromised and is at risk of bacterial contamination.
Source: www.fda.gov

A New Online Guide to Hearing Aids
FDA launches a new Web site that focuses on hearing aids.
Source: www.fda.gov

Recalls and Safety Alerts: Emergency Use of Peramivir to Treat H1N1

2010-01-14T15:52:00.001-08:00

Recalls and Safety Alerts: Emergency Use of Peramivir to Treat H1N1
FDA has authorized the emergency use of the investigational antiviral drug peramivir for certain adults and children hospitalized with confirmed or suspected 2009 H1N1 influenza. This includes patients who have an influenza A virus that is non-subty...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Preventing Anaphylactic-type Reactions with Dexferrum
American Regent has issued new precautionary measures for preventing anaphylactic-type reactions when administering Dexferrum (iron dextran injection). An updated boxed warning for Dexferrum now says that a test dose should be administered befor...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Warning Against Nebulizing Relenza Inhalation Powder
GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophyl...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Serious Complications with Negative Pressure Wound Therapy
FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from...
Source: www.accessdata.fda.gov

U.S. Attorney News Release: Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical Devices

2010-01-13T13:28:00.001-08:00

U.S. Attorney News Release: Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to Its Medical Devices
Spectranetics Corporation, a medical device manufacturer, located in Colorado Springs, Colorado, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced today.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: October 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund.
Source: www.fda.gov

FDA Takes Action Against New Jersey Cheese Manufacturer
The U.S. Food and Drug Administration today announced intentions to ask a federal court to shut down a New Jersey cheese manufacturer with an alleged history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes.
Source: www.fda.gov

Improper Use of Decorative Contact Lenses May Haunt You
As Halloween approaches, FDA reminds consumers that non-prescription decorative contact lenses may harm their vision.
Source: www.fda.gov

Warning on Body Building Products (video)
In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Source: www.fda.gov

Negative Pressure Wound Devices Draw FDA Notice, Advice
FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy.
Source: www.fda.gov

FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters

2010-01-12T13:11:00.001-08:00

FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters
The U.S. Food and Drug Administration is advising consumers to avoid eating oysters harvested from the San Antonio Bay on or after Nov. 16 due to reports of norovirus-associated illnesses in some people who had consumed oysters harvested from this area, which is located on the Gulf of Texas.
Source: www.fda.gov

FDA Warns Public of Continued Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.
Source: www.fda.gov

FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters

2010-01-10T13:47:00.001-08:00

Thermoflect Blankets and product line - Recall

2010-01-08T22:23:00.001-08:00

Thermoflect Blankets and product line - Recall
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Source: www.fda.gov

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter
Potential association between Lexiva and myocardial infarction in HIV infected adults.
Source: www.fda.gov

Stryker Operating Room System II Surgical Navigation System - Recall
A potential for the navigation PC SPC-1 component to stop working which could result in potential harms associated with this failure.
Source: www.fda.gov

Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects
Increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products during pregnancy.
Source: www.fda.gov

FDA Makes Interim Recommendations to Address Concern of Excess Radiation Exposure during CT Perfusion Imaging

2010-01-07T10:41:00.001-08:00

FDA Makes Interim Recommendations to Address Concern of Excess Radiation Exposure during CT Perfusion Imaging
As part of an ongoing investigation into cases of excess radiation during CT perfusion imaging of the brain, the U.S. Food and Drug Administration today provided imaging facilities and practitioners with interim recommendations to help prevent additional problems.
Source: www.fda.gov

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center
Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States. The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP). It was created on the recommendation of President Obama’s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century.
Source: www.fda.gov

FDA Takes Action Against New Jersey Cheese Manufacturer
The U.S. Food and Drug Administration today announced intentions to ask a federal court to shut down a New Jersey cheese manufacturer with an alleged history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes.
Source: www.fda.gov

Food Defense Tool from FDA and APHIS Helps Farmers, Producers Assess Vulnerabilities
The FDA of the U.S. Department of Health and Human Services and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) have created an online tool to help farmers and producers assess and mitigate vulnerabilities in their production processes.
Source: www.fda.gov

FDA Seizes More Than $1 Million Worth of Food from Nashville Food Processor and Warehouse: Agency acts to prevent distribution of food from rodent-infested facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized bulk restaurant food products at Won Feng Trading Company, a food processor and warehouse in Nashville, Tenn. The products are adulterated under the Federal Food, Drug, and Cosmetic Act because they have been held under unsanitary conditions whereby they may have become contaminated with filth. The Act uses the term "insanitary" to describe such conditions.
Source: www.fda.gov

FDA’s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine
An article by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, titled “A Difficult Balance – Pain Management, Drug Safety, and the FDA,” appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.
Source: www.fda.gov

Warning on Body Building Products (video)
In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Source: www.fda.gov

Texas Department of State Health Services Issues Warning Against "Nzu" Products
Texas Department of State Health Services Issues Warning Against "Nzu" Products
Source: www.fda.gov

FDA's International Posts: Improving the Safety of Imported Food and Medical Products
The posting of FDA staff in overseas regions is a key part of the agency's strategy for expanding oversight of imported food and medical products.
Source: www.fda.gov

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center

2010-01-04T23:31:00.001-08:00

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center
Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States. The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP). It was created on the recommendation of President Obama’s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century.
Source: www.fda.gov

Texas Department of State Health Services Issues Warning Against "Nzu" Products
Texas Department of State Health Services Issues Warning Against "Nzu" Products
Source: www.fda.gov

Recalls and Safety Alerts: Certain Unomedical Pulmonary Resuscitators Recalled

2010-01-03T20:30:00.001-08:00

Recalls and Safety Alerts: Certain Unomedical Pulmonary Resuscitators Recalled
The device company Unomedical Inc. is recalling some of its manual pulmonary resuscitators. A malfunction of these devices may make it difficult to generate enough positive pressure to resuscitate a patient properly, and that could lead to serious a...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Reporting Adverse Events to FDA?s MedWatch
An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up i...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Important Changes for Heparin
FDA is notifying healthcare professionals and patients about a new USP monograph for heparin. Under the new monograph, the reference standard used to determine the potency of the drug will be changed in order to make it compatible with the WHO Inter...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Boxed Warning about Tissue Injury with IV Promethazine
FDA is requiring that promethazine hydrochloride injection products carry a boxed warning to communicate more strongly about the danger of giving the drug intravenously. The warning states that intra-arterial and subcutaneous administration of prome...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Medtronic Sutureless Connector Catheters Incompatible with IsoMed Pumps
Medtronic Neuromodulation is alerting healthcare professionals and patients that the company's Sutureless Connector (SC) catheters and revision kits are not compatible with IsoMed implantable infusion pumps. The product labeling incorrectly stat...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Radiation Overdoses from CT Scans
FDA is investigating a situation in which more than 200 patients undergoing CT brain perfusion scans at a single hospital received overdoses of radiation. In some cases the radiation doses were high enough to produce erythema and hair loss. While...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Philips HeartStart AEDs Recalled
Philips Healthcare is recalling certain HeartStart FR2+ automated external defibrillators. These AEDs are used by hospitals, fire departments and emergency medical services to treat sudden cardiac arrest. The recalled devices may have a memory chip...
Source: www.accessdata.fda.gov

U.S. Attorney News Release: Camano Island Man Indicted for Scheme to Steal and Sell Diabetic Supplies

2010-01-02T23:29:00.001-08:00

U.S. Attorney News Release: Camano Island Man Indicted for Scheme to Steal and Sell Diabetic Supplies
MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment.
Source: www.fda.gov

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center
Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States. The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP). It was created on the recommendation of President Obama’s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century.
Source: www.fda.gov

FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters
The U.S. Food and Drug Administration is advising consumers to avoid eating oysters harvested from the San Antonio Bay on or after Nov. 16 due to reports of norovirus-associated illnesses in some people who had consumed oysters harvested from this area, which is located on the Gulf of Texas.
Source: www.fda.gov

FDA Debars Convicted Virginia Seafood Dealer from Importing Food for 20 Years
A Virginia man sentenced to five years in prison for his role in a conspiracy to import catfish from Vietnam for fraudulent sale to avoid paying federal import tariffs has been barred from importing articles of food or offering such articles for import into the United States for the next 20 years, the U.S. Food and Drug Administration said today.
Source: www.fda.gov

Recalls and Safety Alerts: Philips HeartStart AEDs Recalled

2010-01-01T21:52:00.001-08:00

Recalls and Safety Alerts: Philips HeartStart AEDs Recalled
Philips Healthcare is recalling certain HeartStart FR2+ automated external defibrillators. These AEDs are used by hospitals, fire departments and emergency medical services to treat sudden cardiac arrest. The recalled devices may have a memory chip...
Source: www.accessdata.fda.gov

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter
Potential association between Lexiva and myocardial infarction in HIV infected adults.
Source: www.fda.gov

Nzu, Traditional Remedy for Morning Sickness
Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
Source: www.fda.gov

CT Brain Perfusion Scans Safety Investigation: Initial Notification
[UPDATED 12/07/2009] FDA identified at least 50 additional patients exposed to excess radiation; interim recommendations for imaging facilities provided.
Source: www.fda.gov

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
Recall expanded from November recall of 5 lots due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Source: www.fda.gov

Steris System 1 Processor: FDA Notice and Recommendations
[UPDATED 12/17/2009] List of alternative products added. Unapproved device with potential for improper sterilization and disinfection.
Source: www.fda.gov

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010

2009-12-30T15:23:00.001-08:00

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.
Source: www.fda.gov

FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema
The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).
Source: www.fda.gov

FDA Launches New Pet Health and Safety Widget
The U.S. Food and Drug Administration today launched its pet health and safety widget for consumers as part of an ongoing effort to provide timely, user-friendly, public health information.
Source: www.fda.gov

U.S. Attorney News Release: Camano Island Man Indicted for Scheme to Steal and Sell Diabetic Supplies
MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment.
Source: www.fda.gov

FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.
Source: www.fda.gov

FDA Expands Presence Outside U.S. with Opening of Mexico City Post
As part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas, the U.S. Food and Drug Administration today announced the opening of its Mexico City post. This is the Agency’s third post in Latin America and its tenth international post in the past 13 months
Source: www.fda.gov

FDA Debars Convicted Virginia Seafood Dealer from Importing Food for 20 Years
A Virginia man sentenced to five years in prison for his role in a conspiracy to import catfish from Vietnam for fraudulent sale to avoid paying federal import tariffs has been barred from importing articles of food or offering such articles for import into the United States for the next 20 years, the U.S. Food and Drug Administration said today.
Source: www.fda.gov

FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.

2009-12-29T13:09:00.001-08:00

FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.
The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigerated can result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
Source: www.fda.gov

U.S. Attorney News Release: Former New Hampshire Registered Nurse Pleads Guilty for Tampering With Dilaudid and Demerol Syringes at Southern New Hampshire Medical Center
On December 3, 2009, in U.S. District Court, Trinidad Smith, 28, of Manchester, NH, pleaded guilty to an indictment charging her with violations involving consumer product tampering and obtaining a controlled substance by fraud or deception.
Source: www.fda.gov

FDA Takes Action Against Dairy Farm and Owner
On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs.
Source: www.fda.gov

FDA Teams with Everyday Health to Expand Reach of Health Information
FDA expands its reach to millions of consumers through a new partnership with Everyday Health.
Source: www.fda.gov

Negative Pressure Wound Devices Draw FDA Notice, Advice

2009-12-27T22:33:00.001-08:00

Negative Pressure Wound Devices Draw FDA Notice, Advice
FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy.
Source: www.fda.gov

Consejos de seguridad de los alimentos para unas fiestas saludables
Los consumidores tienen una función que cumplir, sobre todo cuando manipulan los alimentos en el hogar.
Source: www.fda.gov

Improper Use of Decorative Contact Lenses May Haunt You (video)
FDA reminds people, in time for Halloween, that non-prescription decorative contact lenses may harm their vision.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: November 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Recalls and Safety Alerts: Boxed Warning about Tissue Injury with IV Promethazine
FDA is requiring that promethazine hydrochloride injection products carry a boxed warning to communicate more strongly about the danger of giving the drug intravenously. The warning states that intra-arterial and subcutaneous administration of prome...
Source: www.accessdata.fda.gov

The Word is Out on Unapproved H1N1 Products
FDA has stepped up its campaign to inform consumers of—and protect them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the H1N1 flu virus.
Source: www.fda.gov

Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness
Source: www.fda.gov

Improper Use of Decorative Contact Lenses May Haunt You
As Halloween approaches, FDA reminds consumers that non-prescription decorative contact lenses may harm their vision.
Source: www.fda.gov

LASIK: Quality of Life Project, Warning Letters to Facilities
On October 15, 2009, the U.S. Food and Drug Administration (FDA) launched a study of the impact of LASIK on patients' quality of life, and issued warning letters to 17 LASIK surgery centers that release patients the same day as their surgery.
Source: www.fda.gov

Health Fraud Awareness (video)
Learn how to spot health fraud and avoid it with this FDA Consumer Update video.
Source: www.fda.gov