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Dangerous Drugs & Recalls

DRUG RECALLS SURGE IN THE U.S.

Recalls of prescription and over the counter drugs are surging, raising ques­tions about the quality of drug manufac­turing in the United States. Drug recalls totaled 296 from January through June of this year. If this trend continues there could be 600 or more recalls by the end of the year, which is a very high rate of recalls.  

The increase in recalls, especially of generic and over-the-coun­ter drugs, is being driven by manufactur­ing lapses. Some of the biggest culprits: the quality of raw materials, faulty label­ing and packaging and contamination.

A number of factors appear to be fueling the recall surge. The stampede by drugmakers to be first to bring generic versions to market, after drugs lose patent protection, is one of these factors. Generic drugs account for about three quarters of all prescription drug sales, according to industry group PhRMA. Source: CNN

A drug recall is an action taken to remove a prescription or over-the-counter drug from the market. 

Many countries have a government agency responsible for overseeing the safety and efficacy of pharmaceutical drugs. In the United States, the Food and Drug Administration (FDA) is responsible for a variety of products, including drugs, medical devices and foods. The FDA provides clinical information about safety issues involving prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products, including dietary supplements. The FDA issues and announces recalls, safety alerts, withdrawals, and important labeling changes that may impact the health of consumers. 

Drug recalls are often categorized by class:

  • A Class I recall occurs where a reasonable probability that the use of or exposure to a product will cause serious injury or death;
  • A Class II recall occurs where use or exposure to a product may cause temporary or medically reversible injury;
  • A Class III recall are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations; and
  • A safety alert is a notice or warning issued in situations where a product may present an unreasonable risk of substantial harm.

The FDA expects drug makers to take responsibility for product recalls, including follow-up checks. When a product is discovered to pose a safety risk or defect, drug makers or distributors will often carry out recalls voluntarily. In other instances, the FDA may inform a company of findings that one of its products is defective and suggest or request a recall. If the firm refuses to recall the product, the FDA may seek legal action under the Federal Food, Drug, and Cosmetic Act. Such legal action may include seizure of available product, and/or injunction of the company, including a court request for recall of the product. 

The recall of a defective or harmful drug is sometimes publicized in the media. Often the drug maker will issue its own press release. The FDA publicizes a recall only when it believes the public needs to be alerted about a serious hazard. 

After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.

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