Please provide an incident for a drug product that caused recall from market type of issue in the USA.

• Why approved and marketed drug product in the U.S must be pulled from the market by FDA due to safety concern? Such as Serious adverse events, deaths, or any adverse events.
• What is the important role of Data monitoring committee ? What were their findings?
• What do you think what went wrong with this drug product?
• What do you think that drug manufacturing company could have done differently?