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FDA Enforcement Report Index

The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved.

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Recalls, Product Withdrawals, and Safety Alerts

Recall and Field Correction: Action taken by a firm to either remove a product from the market or to conduct a field correction. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Medical Device Notification or Safety Alert: Any communication issued by a manufacturer, distributor, or other responsible party or FDA to inform health professionals or other appropriate persons or firms of a risk of substantial harm from a medical device in commercial use. Notifications are issued at the request of FDA. Safety Alerts are voluntarily issued.

Injunction: A civil action taken against an individual or firm seeking to stop continued production or distribution of a violative product.

Seizure: An action taken to remove a product from commerce because it is in violation of the law. FDA initiates a seizure by filing a complaint with the U.S. District Court where the product is located. A U.S. marshal is then directed by the court to take possession of the goods until the matter is resolved.

Prosecution: A criminal action taken against a company or individual charging violation of the law.

Disposition: A final order entered by a court to conclude cases involving prosecutions or injunctions. Prosecutions may conclude with the entry of a plea, a verdict, and, if guilty, conviction and sentencing. Injunctions are resolved when a court imposes an order on a firm or declines to issue the order.

Indictment: A formal accusation by a grand jury that sets forth charges against a defendant and states when the alleged crime occurred. An indictment is not a finding of guilt. Guilt can only be determined by a judge or jury after a trial.

Information: A formal accusation by a U.S. attorney similar to an indictment except that the charges usually are not presented to a grand jury. An information alleges a misdemeanor rather than a felony except when consented to by the proposed defendant.

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