There are three different ways food products, medical drugs, and medical devices can be recalled:
- At the initiative of the manufacturer of the defective food or drug
- At the request of the Food and Drug Administration (FDA)
- Upon order of the Food and Drug Administration (FDA), pursuant to its authority under federal law
The way in which a food or drug recall happens depends in part on what type of recall is at issue. The FDA divides recalls into three different classes, based on the likelihood that the defect in the food product or drug will cause serious injury or death.
- Class I recalls occur when there is a reasonable probability that the dangerous food or drug will cause serious illness or death. An historic example of a Class I recall is the infamous Tylenol recall of 1982, when the company pulled 31 million bottles of Tylenol from retail shelves after learning that some unknown quantity of bottles had been deliberately contaminated with cyanide.
- Class II recalls occur when use of the dangerous food or drug would cause temporary or medically reversible illness or when the chance of serious illness is remote. An example of a Class II recall would be if a company pulled frozen dessert bar products because the labeling information failed to include required details about artificial coloring products.
- Class III recalls occur when the food or drug defect is unlikely to cause any adverse health effects but still violates FDA manufacturing or labeling standards. A common example of a Class III recall is when an imported food product is pulled from the shelves because it does not include ingredient information in English.
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Contact Shaffer & Gaier After a Serious Accident
If you or a loved one has suffered injury due to a defective food product or pharmaceutical drug, Shaffer & Gaier can help. To set up a free initial consultation, contact our office online, call our Philadelphia office location at 215-751-0100, or call our New Jersey office at 856-429-0970.
