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  1. Drug Recalls

FDA's Role in Drug Recalls

A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market. Drug recalls may be conducted on a company’s own initiative or by FDA request. FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall.

Recall Classification

  • Class I: A dangerous or defective product that could cause serious health problems or death.
  • Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.
  • Class III: A products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

Alerting the Public
Not all recalls are announced on FDA.gov or in the news media. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through notification from the manufacturer, their health care professional or pharmacist.

If you have a medicine that has been recalled, talk to your health care professional about the best course of action for your health, including the possibility of returning the product to the store in which you purchased it.

Stores generally have a return and refund policy when a company has announced a recall of its products. Generally, Class I recall notifications provide instructions with actions for patients. FDA recommends that patients follow the instructions provided by the recalling company.

Weekly Enforcement Report
All recalls are posted weekly in the FDA enforcement report. Recalls that are classified will have a classification of Class I, Class II or Class III based on the level of hazard. Ongoing recalls that have not been classified are also published in the enforcement report as “not yet classified” in the classification field. After the recall classification has been determined, the recall is updated in the enforcement report with its appropriate classification.

Determining the Effectiveness of the Recall
FDA evaluates the effectiveness of a recall by evaluating a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective FDA will request the company take additional actions.




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