What Is A Drug Recall?

Drug Recall/ RxRecalls/ The Maher Law Firm

 

Drug Recall

A drug recall is issued when a drug becomes dangerous to the consumer.  Drug safety is strictly monitored by the Food And Drug Administration (FDA) in the U.S. before going on the market.  Once it is on the market the FDA and the drug manufacturer continue to monitor the effectiveness and safety of the drug.  If any problems arise regarding safety of the drug then a recall is issued.

Drug Recall Classifications

There are three classifications for drug recalls depending on how harmful the drug could be.

  •  Class 1 Recall:

    Reasonable probability that using the drug will cause serious adverse health consequences or death.

  •  Class 2 Recall:

    Using the drug may cause temporary or medical reversible adverse health consequences,  the probability of serious adverse health consequences is remote.

  •  Class 3 Recall:

    Using the drug is not likely to cause adverse health consequences.

The FDA can issue a recall or the drug manufacturer can voluntarily recall a drug and take it off the market.

 

Safety Notice

A safety notice is a warning to the public when a medical product or device is at high risk of causing serious harm to users.  A safety alert can turn into a recall in which case the product would be taken off the market,

 

 

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