The Food and Drug Administration (FDA) is the federal agency that protects our food supply and regulates drugs (both prescription and over-the-counter) and medical devices.
The FDA may issue a recall based upon the threat level of a drug. The type of drug involved in a Class 3 recall varies, but this level of recall deals with drugs least likely to cause adverse health outcomes. According to the FDA, the agency uses this classification of recall for medications “unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.”
Understanding Recalls Based Upon FDA Classification
The FDA classifies recalls on a scale from one to three, depending on the likelihood of the drug, product, or device causing drastic health outcomes:
- Class I: Reserved for products that more than likely will cause harmful health consequences, including death.
- Class II: The most common type of recall, used when a drug might cause temporary or less serious health consequences.
- Class III: Used for prescription and over-the-counter medicines that do not meet FDA labeling or manufacturing standards but are deemed unlikely to cause adverse health consequences.
The FDA lists recalled products for all classes of recalls on its website and Twitter feed.
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Recent Class 3 Drug Recalls
It would likely surprise most consumers to learn that the FDA issues hundreds of Class 3 drug recalls every year.
According to the FDA Enforcement Report, some recent recalls include:
- Namenda XR: The brand name for memantine hydrochloride, used to treat Alzheimer’s and other cognitive disorders.
- Furosemide: A prescription medicine for treating edema in patients with congestive heart failure, renal disease, and cirrhosis of the liver.
- Lutera: An oral contraceptive for women that also addresses other hormonal and reproductive issues.
Among the reasons why the FDA would select a Class 3 recall for these and other drugs include:
- Errors or omissions in labeling or packaging.
- Solubility or other efficacy irregularities.
- Missing components (such as a dosing cup if the manufacturer is supposed to provide one).
- Temporary adverse health consequences in a small group of users.
How to Know if Your Class 3 Drug Is Involved in a Class 3 Recall
The manufacturer typically initiates most drug recalls voluntarily, but the FDA sometimes compels a drug recall.
You can learn whether a drug you use is subject to a recall notice in several ways, including:
- Public announcement by the FDA on television, social media, and its website.
- Public announcement by the drug’s manufacturer on television, social media, print ads, direct mailers, and its website.
- Personal communication from your healthcare provider or network, including some prescription discount programs.
- Public announcement by your pharmacy.
- Public report by a consumer advocacy group, such as Consumer Reports.
You can check for recalls using the drug name, manufacturer, or lot number, which you can find on the bottle or packaging.
What to Do if Your Drug Is Involved in a Class 3 Recall
If a manufacturer or the FDA recalls a drug you use, you might think you need to stop taking it immediately. However, that may be unnecessary, and it could also cause unpleasant or adverse consequences.
The safest course of action is for you to check with your healthcare provider. While you could safely discontinue over-the-counter drug usage, prescription drugs may be critical for your health.
Your doctor can help you understand the benefits and risks of stopping or changing medication.
Safe Disposal of Recalled Drugs
If the best action is for you to stop taking a recalled drug, you must find safe ways of disposing of it, reducing the chance of you or someone else accidentally taking it.
Sometimes, the FDA or manufacturer will offer specific disposal instructions. Safe disposal of drugs depends on certain factors, such as:
- If the recalled drug is a controlled substance.
- If you can safely flush the drug down the toilet.
- If you must dispose of the drug at an authorized takeback site (the Drug Enforcement Administration (DEA) has an approved list of disposal locations).
In most cases, you can safely dispose of medications in your household trash, provided that your local jurisdiction does not prohibit this action.
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What to Do if a Recalled Drug Made You or a Loved One Sick
While the FDA uses Class 3 recalls for drugs with the least risk of severe health consequences, people can still become sick.
Your priority is your health and safety and that of your loved ones. However, if the injury or illness caused you damages in the form of medical bills, lost pay, and other losses, you might want to call a lawyer who handles defective drug cases.
How You Could Recover Damages
A personal injury lawyer who accepts defective drug cases could help you recover compensation by showing liability on the manufacturer’s part for failing to protect you from harm.
The steps for seeking compensation after suffering harm from a defective drug typically include:
- Notifying the at-fault party of your injuries.
- Securing evidence of your injuries and damages.
- Pursuing money damages from the liable party.
You or your loved one could receive awards no matter which type of drug is involved in a Class 3 recall.
Statute of Limitations
Each state has a statute of limitations, or deadline, for taking legal action to pursue compensation. A court will likely dismiss any lawsuit filed after the deadline.
Call Today for More Information
If you or a loved one became ill from a drug subject to a Class 3 drug recall, you could call the team at Ben Crump Law, PLLC, today at (800) 983-6116 for a free case review.