Drug Recall

定義

The removal or correction of a marketed drug product that the FDA considers to be in violation of laws or presents a risk to health. Recalls are classified as Class I (serious risk of injury or death), Class II (temporary or reversible), or Class III (unlikely to cause harm).

関連用語

ガイドでの言及

• Drug Recalls: What You Need to Know
  What triggers a drug recall, how recalls are classified, and exactly what you should do if a medication in your …
• How to Check If Your Drug Has Been Recalled
  A practical, step-by-step guide for checking whether a specific medication in your home is subject to an active FDA recall …