Drug Liability Lawsuits

What is a drug recall?

A drug recall is when a prescription or over-the-counter medication is removed from the market because it is defective or otherwise potentially harmful. Sometimes, this is because the FDA has determined that the drug has too many associated risks, but in other cases, the manufacturer itself chooses to pull the drug from store shelves.

It’s important to know how to check for recalls, and why a recall might be in effect. A drug could be recalled for the following reasons:

Health risks
Drugs go through rigorous testing well before they get to the store shelves. But, there are situations in which a drug’s risks are not understood or recognized until it has been used for many years. Sometimes this happens because the studies and trials were not lengthy enough to see the long-term effects. It could also happen when the trials do not account for the range of patients that the drugs will ultimately be used to treat; for example, it might not look at patients with preexisting conditions that might be affected by the new drug. While the FDA always does extensive research and testing, drug recall actions can happen because in some cases a patient would need to take a drug for many years — maybe even decades — before a negative effect would start to show symptoms.

Newly discovered drug interactions
Another cause for a drug to be recalled could be its interactions with other drugs. How a drug is handled by the human body varies on an individual basis because each person’s absorption, distribution, metabolism and excretion of the drug will be different. That means that even that long list of side-effects printed on a drug package insert cannot include the entire range of possible interactions.

Manufacturing error
Sometimes a drug is inherently safe, but a mistake is made in the manufacturing process. When that happens, specific batches of the drug can be recalled, but production continues and it will eventually be returned to market. A manufacturing mistake could be some contaminant in the batch, bacteria, or even the wrong proportions of ingredients.

Packaging information error
On occasion, a drug can be recalled even though the drug, itself, is completely fine. When it comes to medications, though, the small print on those little inserts in the box is just as important as the medication. That’s because any medication, if taken at the incorrect dosage, or not to the correct specifications, can be dangerous or even lethal. It’s also why a drug recall might occur if a medication’s dosing instructions, ingredient list, list of common side-effects, interactions or other information is incorrect. It’s important that doctors, patients and pharmacists have accurate information when dosing and prescribing drugs so that each patient takes a medication appropriately for his or her treatment and medical conditions.