Saturday, November 21, 2009

FDA Warns Bayer About Two Unapproved Aspirin Products

On Oct. 28, 2008, the Food and Drug Administration (FDA) sent warning letters to Bayer HealthCare regarding two over-the-counter (OTC) products that combine aspirin with a dietary supplement into a single pill. The products are not approved by FDA.

Which products are affected?


Bayer Aspirin with Heart Advantage (Bayer Heart Advantage)–aspirin combined with phytosterols (a plant-based supplement also known as plant sterols)

Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's)–aspirin combined with calcium
 
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What action is FDA announcing?

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