Once a product is in widespread use, unforeseen problems can sometimes lead to a recall. Contaminated spinach, for example, led to the recent recall of spinach products under multiple brand names. Contaminated peanut butter led to the recall of thousands of jars of two popular brands. In both cases, FDA responded immediately to minimize harm.
When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. In most cases, a recall results from an unintentional mistake by the company, rather than from an intentional disregard for the law.
The Food and Drug Administration (FDA) has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma.
On Feb. 18, 2010, the agency said
LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses...
Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.
FDA first hears about a problem product in several ways:
A company discovers a problem and contacts FDA.
FDA inspects a manufacturing facility and determines the potential for a recall.
FDA receives reports of health problems through various reporting systems.
The Centers for Disease Control and Prevention (CDC) contacts FDA.
When it comes to illnesses associated with food products, Dorothy J. Miller, Director of FDA's Office of Emergency Operations, says that FDA generally first hears of these kinds of problems from CDC.
"CDC hears about such problems from state health departments that have received and submitted illness reports," she says. "An ongoing outbreak means that we have an emergency, and when there's a public health crisis like this, you need to tell the public immediately."
Alerting the Public
FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people. FDA can hold press conferences, issue press releases, and post updates to its Web site regularly, to alert people.