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Top 5 Reasons Drugs Are Recalled

Published on Mar 30, 2021 by Thomas Law Offices.

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It’s estimated that over 4,500 drugs and devices are removed from pharmacy shelves every year. The recalled products often have prior Food and Drug Administration (FDA) approval, which means they have likely been widely used prior to being pulled. It is likely you, or someone you know has had a prescription medication or over-the-counter drug recalled. In order to understand why, let’s take a look at the top five reasons drugs are recalled.

1) The drug poses potential health risks.

When the FDA approves a drug, consumers assume it is safe to ingest, implant, or use as directed. Any major potential health risks are normally not brought to light until the medication has been widely distributed. For example, medicines containing phenylpropanolamine were recalled in the early 2000s because of the increased risk of hemorrhagic stroke—also known as bleeding on the brain. Phenylpropanolamine was found in common decongestants and weight loss medicines—which meant that hundreds of thousands, if not millions of people, were exposed. Other health risks that have resulted in medication recalls include cancer, lung conditions, stroke, and death.

2) The medication is contaminated.

Contaminated medications contain everything from hazardous bacterial to glass particles. In some instances, they may contain too much or too little of the drug’s active ingredient. Contamination happens because of issues with tracking drugs. For example, it’s not always clear where drug makers buy their ingredients. This is often because the active pharmaceutical ingredient that makes the drug is a trade secret. In addition to that, which drugs are made in each facility is considered a trade secret, so the FDA won’t reveal which drugs were made in which plants, including those cited for sanitary concerns and other hazards.

3) The contents of the package do not match the label.

Anyone who takes prescription medications should verify the label before taking anything. The three things you should check for every time are your name, your dosing and storage instructions, and your refill instructions. If any of that information seems incorrect, consult your pharmacist and doctor to verify you have what you need, and you know how to take it. In rare instances, the medication inside a drug package is not correct. Before taking a new pill, make sure you verify what the medication looks like. If you have taken the same medication for a long time and all of a sudden the medication looks different, verify the medication with your pharmacist.

4) The medication label is unclear or misleading.

Medication labels are often unclear because manufacturers are only required to include the drug maker, the labeler, or the distributor. They do not need to include all three. In addition to that, sometimes medications come with confusing dosing instructions or problems with the dosing tool provided. As a result, a patient could end up receiving too little or too much of their given prescription. According to the American Medical Association, around 50% of United States patients do not understand the health information they receive—including the labels on their medication. This is because the average adult reads at an eighth-grade level, while prescription labels are written for college graduates.

5) The manufacturer made a mistake.

Manufacturing defects can impact a product’s quality, purity, and potency. This type of mistake can happen at any point in the manufacturing process and can either impact a particular lot of a medication or an entire product line. A drug that’s affected during the manufacturing process may leave patients with a worsening condition. Substandard drugs are a growing problem in the United States. Both generic and innovator medicines can be impacted, which can lead to loss of confidence in medicines, healthcare providers, and health systems. Substandard drugs are also known to contribute to antimicrobial resistance and drug-resistant infections, making it easier to spread illnesses.

If you discover one of your medications has been recalled, don’t panic. You can research the recall via the FDA website and notify your pharmacist. If you notice something unusual about the medication and are experiencing new or strange side effects, call your doctor immediately. You never want to stop prescription medications cold turkey, so it’s important to consult your doctor first to find out how to handle the situation best.

In the event you think you’ve suffered injuries because of medication, our dangerous drug lawyers can help. We’re aware of all the class action drug lawsuits, and we can determine if you have grounds to pursue legal action. Contact us today for more information.

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Tad Thomas - Trial Lawyer

Tad Thomas

Managing Partner

Tad Thomas has dedicated his practice to representing plaintiffs in various types of civil litigation, including personal injury, business litigation, class actions, and multi-district litigation.

After graduating with his law degree in 2000 from Salmon P. Chase College of Law at Northern Kentucky University, Mr. Thomas immediately opened his own private practice and began representing injury victims.

In 2011, Thomas Law Offices was established in Louisville, Kentucky. Over the past decade, Mr. Thomas has expanded his firm and now has offices in three additional locations: Cincinnati, Ohio, Columbia, Missouri, and Chicago, Illinois. He is also a frequent lecturer on topics like trial skills and ethics and technology.

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