Recalled and Withdrawn Drugs
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Drugs and medical devices are often recalled by the FDA or withdrawn by the manufacturer (after prompting by the FDA) because they pose a health risk to the patient. These health risks can range from being minor to involving death of patients.
- Class I recalls involve the most dangerous drugs and devices. These recalls include products that will most likely cause serious, adverse health reactions.
- Class II recalls involve products that are likely to cause temporary, or medically reversible, adverse reactions.
- Class III involves products that are unlikely to cause adverse reactions, but pose enough threat to be withdrawn from the market.
- Withdrawn drugs and devices are taken off the market voluntarily by manufacturers. Tampering is one reason products are withdrawn.
There were two drugs recalled in the first part of February 2008: Simvastatin Tablets and IVAX Aspirin Tablets. They were both listed as Class II recalls.
The Simvastatin bottles were reported to contain some Carvedilol pills instead of pure Simvastatin. Simvastatin is used to lower cholesterol and Carvedilol is used to treat congestive heart failure.
The IVAX Aspirin was recalled because the product may be unpure, resulting in unexpected health consequences.
There were also hundreds of recalled packages of human plasma. Many were recalled because donors were discovered to be at risk for certain diseases, or they were discovered to be HIV+ after the blood was released from the donor bank.
To find out about more recalled drugs and products, click on the “Drug Injury” tab above, or visit www.fda.gov.