A recall is when a company takes a product off the market. The action can be of the company's own will or requested by the FDA (Food and Drug Administration), the agency responsible for handling food related recalls, including drugs.
Drug manufacturers aim to get their products right the first time, whether it's simply easing a headache or a ground-breaking cancer fighting drug. Plus, it costs less, in the long run, to produce a safe product that genuinely benefits its users. The goal is for each product to fix what it is intended to fix.
When a drug causes harm or a problem is found in the manufacturing process, the FDA steps in and initiates the recall process. In this article, you'll learn what causes a recall to be issued and what you can do if you find yourself with a recalled product.
What causes a drug recall?
The recall process can be confusing. There are four different agencies that are responsible for the safety of both people and animals. The FDA is just one of these agencies, and they keep an eye on everything that goes into our bodies including drugs and tobacco products, for both people and animals. The exception is beer, wine, and liquor, which fall under the Bureau of Alcohol, Tobacco, and Firearms. Shellfish - both fresh and frozen - are also managed under a different agency called the ISSC.
The term "drugs" includes items like OTC (Over-The-Counter) medicines, prescriptions, medical devices, blood, and transplantable tissue. When looking at drugs, the FDA wants to know if the product is defective, causes harm, or is in violation of regulations or laws. Unfortunately, recalls happen on a regular basis. They are triggered in one of four ways:
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A company discovers they have a problem and contacts the FDA
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An FDA inspection of a facility turns up problems that merit a recall
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The CDC contacts the FDA about a foodborne illness report
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The FDA learns about a problem through reports from other (state, local, etc) health reporting systems
The company will often issue recalls if they discover a problem, but the FDA has the authority to request or, in the case if infant formula among other things, demand a recall.
How bad is the drug recall?
The FDA uses a class system to let the public know the severity of the recall:
Class I: products that have a "reasonable likelihood" of "serious adverse health consequences or death." Things that will badly hurt or kill you.
Class II: Things that might cause harm, but in a "temporary or medically reversible" way and which have "remote" chances of causing severe harm or death.
Class III: Things that are not likely to cause adverse health consequences, but that still violate legal regulations in some way.
For example, if the warning label on a bottle of Advil gets cut off during the manufacturing process, that's a Class III. The manufacturer is in violation by not displaying the label in its entirety to let the public know of the potential side effects. However, if an assembly line happens to be contaminated by a harmful substance, that's a Class I as it can have serious adverse health consequences on consumers.
Do you have a product that has been recalled?
The FDA features an ongoing list of products that have been recalled, drugs included. What if you've found that a drug you have has been recalled? There are a few things you should know:
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Don't panic. Most drug recalls are for minor issues.
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Stop taking the medicine.
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Talk to your physician or pharmacist, and ask if there is an alternative medicine you can take.
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Check to see if the manufacturer has a hotline for you to call. They will address frequently asked questions as well as give you a platform to express concerns.
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Look at the store's policy on recalled items. Most stores will have a return and/or refund policy in place for recalls.
Recalls happen, but your family should not have to experience the consequences of defective or harmful products. An experienced attorney can help you navigate the ins and outs of a drug recall case.