FDA Alerts & Warnings

Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.

13. March 2012

Posted in: FDA Alerts and Warnings

Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly

Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient.

9. March 2012

Posted in: FDA Alerts and Warnings

Gerber Good Start Gentle Powdered Infant Formula: Recall – Off-Odor

Reports of gastrointestinal complaints.

2. March 2012

Posted in: FDA Alerts and Warnings

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component

Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.

1. March 2012

Posted in: FDA Alerts and Warnings

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication – Interaction Increases Risk of Muscle Injury

Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal.

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Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform

Altuzan (bevacizumab): Counterfeit Product – Contains no Active Ingredient

Celexa (citalopram hydrobromide) – Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms

Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall – Potential for Visible Particulates

Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury

Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly

Gerber Good Start Gentle Powdered Infant Formula: Recall – Off-Odor

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication – Interaction Increases Risk of Muscle Injury

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