San Diego product liability attorneys, we think it is helpful for patients to understand the terminology used
in drug recalls and how it may impact their safety.
While most drugs are recalled for minor issues, others can lead to serious
injury or even death. Therefore, it is important to be informed.
First, a recall is when a product is removed from the market or a correction
is made to the product because it is either defective or potentially harmful.
In some cases, the manufacturer or distributer may discover a problem
and conduct an independent recall. In other cases, the FDA raises concerns
and orders a recall.
For instance, this month, Accord Healthcare announced the recall of a popular
antibiotic, Amoxicillin. In this case, a Class 2 Recall was issued when
the drug maker discovered that the blister foil in some packs of 500 mg
strength capsules was incorrectly labeled as 250 mg.
As highlighted by this case, it is also important to understand that recalls
are also divided into classes, depending on the degree of risk to patients.
The FDA defines the classes as follows:
Class I recall: a situation in which there is a reasonable probability that the use of
or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause
temporary or medically reversible adverse health consequences or where
the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not
likely to cause adverse health consequences.
Market withdrawal: occurs when a product has a minor violation that would not be subject
to FDA legal action. The firm removes the product from the market or corrects
the violation. For example, a product removed from the market due to tampering,
without evidence of manufacturing or distribution problems, would be a
Medical device safety alert: issued in situations where a medical device may present an unreasonable
risk of substantial harm. In some case, these situations also are considered recalls.
What to Do If a Drug Is Recalled
If you are taking an over-the-counter medicine that has been recalled,
you should immediately stop using the medicine and seek a refund from
the seller. If your prescription medicine is recalled, you should contact
your physician immediately.
If you suffer an adverse reaction to a recalled drug, it is also important
to alert your physician. In addition, you may be able to pursue compensation
for injuries sustained from the use of a defective drug or medical device
through a San Diego product liability lawsuit.
If you or someone you love has been seriously injured by a dangerous or
defective drug or medical device, don’t hesitate to
contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.