November 20, 2008
 

Bottled Water Everywhere: Keeping it Safe


Bottled Water Everywhere: Keeping it Safe
Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe.

FDA Warns Bayer About Two Unapproved Aspirin Products
FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill.

Thoratec HeartMate II Left Ventricular Assist System
Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death.

Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator
Class I recall because of unsupported claims.

Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions
An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ...

Is It Really FDA Approved?
Some marketers say their products are "FDA approved", but how can you know for sure?

Draft Guidance on Genetically Engineered Animals
The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals.

Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa)
Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation

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