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indragning av läkemedel

drug recall [ENGLISH]

A drug recall is an action taken by a firm to remove a product from the market that FDA considers to be in violation of the law. Recalls are classified as Class I, Class II, or Class III. Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a volatile product, will cause serious adverse health consequences or death. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination.

indragning av läkemedel [SWEDISH]

Ett läkemedel dras tillbaka från marknaden. Detta sker om ett läkemedel bedöms kunna skada eller orsaka obehag för användaren. En indragning kan gälla en eller flera satser/batcher eller omfatta hela produkten. 


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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