The Varying Significance of a Drug Recall

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May 19, 2020
Edward Smith

The Drug Recall

Medications are recalled for a number of different reasons, some more worrisome than others.  It is always alarming to learn that a drug recall applies to a medication you have been taking regularly.

Below, we discuss a number of reasons why a drug recall may be issued by the U.S. Food & Drug Administration (FDA):

Problems With Labeling

A medication may be recalled due to an issue being identified with its labeling.  Medicine is required to have a label on the container and instructions for usage inside the box.  Often, the instructions will include information such as how often the medication should be taken, the maximum daily dose, and if it should be taken with a meal.

If it is discovered that the included instructions contain incorrect information, that is one reason a batch of drugs may be recalled.  Another example is if the label is wrong.  Perhaps the label indicates the incorrect prescription-strength – 5 mg as opposed to 10 mg, for example.  This could lead to under- or over-dosing and would be a reason for a recall.  

Product Defect

In most cases, when a medication is recalled on the basis that it is defective, it means that it is not effective toward the condition it was intended to treat.  This is not necessarily harmful toward the consumer, and in most cases, simply means you are ingesting a substance for no reason since it is not doing you any good.  

In cases of a recall for a defective product, it is a good idea to stop taking the medication and speak with your doctor about an effective alternative drug for your condition.

Dangerous Drugs

Of course, the most concerning drug recalls are those that are issued because the medication poses a danger to the consumer.  

One recent example of this type of recall was the pulling of Zantac products from the shelves earlier this year.  Zantac was recalled because certain formulations were found to have high levels of n-nitrosodimethylamine (NDMA), a known carcinogen.  In this case, the FDA said that Zantac would no longer be sold and that consumers should stop taking the pills in their possession and dispose of them in a safe manner.

FDA Can Be Slow to Act

In the case of Zantac, the information about the potentially high levels of NDMA had been available for quite some time prior to the medication actually being recalled.  Right now, there are a number of medications still on the market that are being studied to determine if they pose a danger to consumers.

Prudent consumers may want to keep an eye on the reports of such drug studies and take action even before the FDA issues a recall.  Federal agencies can be slow to react.  Oftentimes, a sterner warning will be issued by the FDA as opposed to a full recall.  This is currently the case with the asthma drug Singulair.  Consumers may want to discontinue a drug or seek an alternative on the basis of such pre-recall actions.  

Always speak to your physician before stopping any prescribed medication.  

Consumer Awareness

When a drug recall happens, it is important to understand the reason.  Some recalls are for issues that could have minimal to no effect on the consumer’s health, while other recalls address a real danger or risk with continued use of the drug.

The FDA simply recalls the drug, and often after months or years of research on a medication’s potential danger.  There is no one who comes to your door and disposes of the drug for you.  A good physician may reach out to you if you have been prescribed the recalled medication and advise you to stop taking it.  However, as in many instances, it is ultimately up to the consumer to do their own research, keep up with news, and react to the recall.  

As soon as you learn that a medication you are taking has been recalled, call your physician for advice on how to safely discontinue or switch to an alternative drug.

Below is a news clip discussing the frequency of drug recalls.

Sacramento Drug Products Liability Lawyer

I’m Ed Smith, a Sacramento Drug Products Liability Lawyer. If you or anyone you love has been injured or diagnosed with a condition after taking a dangerous medication, do not hesitate to seek our free, friendly advice at (916) 921-6400 or (800) 404-5400.

I am part of the Million Dollar Advocates Forum and the National Association of Distinguished Counsel.

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