FDA MedWatch
Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure
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
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
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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
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
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.
Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
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.
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
Recall due to balloon inflation assembly that may not hold air
CONSTELLATION Vision System: Recall
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
Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.
Slim- 30 Herb Supplement: Undeclared Drug Ingredient
Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.
Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning
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
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
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
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
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
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
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall
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
A power supply assembly failure can result in the inability to deliver defibrillation therapy.
Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
Drug failed to demonstrate clinical benefit to patients enrolled in trials.
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