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Drug Recall

Définition

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).

Exemple

Ranitidine (Zantac) was recalled in 2020 after NDMA (a probable carcinogen) was found to form in the drug over time.

Termes Associés

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