Food and Drug Adminstration (FDA): MedWatch

Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

07/30/2010 07:54 PM
Increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

07/30/2010 05:30 PM
Product sold online as a dietary supplement. When consumed as instructed, produces an industrial bleach that can cause serious harm to health.

Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient

07/30/2010 03:20 PM
These products, marketed as dietary supplements, contain sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerously low levels.

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

07/29/2010 01:00 PM
Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

07/29/2010 09:00 AM
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

07/21/2010 11:00 PM
Recall due to balloon inflation assembly that may not hold air

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient

07/21/2010 11:00 PM
Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.

CONSTELLATION Vision System: Recall

07/20/2010 02:15 PM
Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

07/20/2010 08:36 AM
Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.

Slim- 30 Herb Supplement: Undeclared Drug Ingredient

07/19/2010 07:32 AM
Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

07/16/2010 01:10 PM
Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

07/15/2010 01:10 PM
A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.

Coumadin 1 mg Tablet Blister Packs: Recall

07/14/2010 07:50 AM
Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

07/13/2010 02:00 PM
Warning highlights the risk of severe liver injury and how this risk may be reduced.

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

07/09/2010 11:35 AM
Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.

Que She Herbal Supplement: Undeclared Drug Ingredients

07/08/2010 02:08 PM
Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

07/08/2010 12:45 PM
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.

McNeil Consumer Healthcare Over-The-Counter Products: Recall

07/07/2010 11:00 PM
UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin.

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall

07/02/2010 07:15 PM
The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

07/02/2010 12:15 PM
A power supply assembly failure can result in the inability to deliver defibrillation therapy.

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