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Drug Recalls and Warnings
Drug Recalls
A drug recall occurs after the Food and Drug Administration receives numerous adverse reaction reports from physicians in regards to a particular drug, or after the manufacturer realizes that there was a deficiency in their manufacturing process. To put it simply, a drug recall removes the affected prescription or over-the-counter drug from the market. Generally, a recall must be warranted by the high likelihood that the drug will cause extremely serious injury or death. While all drug recalls are not to be taken lightly, the FDA classifies them as Category I, II or III.
FDA Recall Levels
Category I: The use of, or exposure to, the recalled drug is most likely capable of causing a serious health issue or even death to the consumer.
Category II: The use of, or exposure to, the recalled drug is not likely to cause a serious health issue. At most, it may cause temporary or medically reversible adverse health consequences.
Category III: The use of, or exposure to, the recalled drug is not likely to cause an adverse reaction.
Black Box Warnings
After a drug has been on the market for some time, issues pertaining to its safety frequently emerge. Following these concerns, the FDA has two options. It can choose to completely remove the drug from the market or it can issue an advisory, the strongest of which is a black box warning which appears on the drug's printed materials, both inside the packaging and on materials developed for the doctors who may prescribe the drug.
Important Considerations
Each state has specific laws governing the types of claims an injured person may bring as well as the type of compensation they may seek in a pharmaceutical injury case. Therefore a person who is injured by a drug or product should seek prompt legal assistance from an attorney to make sure that their rights are protected.