Nationwide Duloxetine Recall Updated – FDA Sets Risk Class

October 22nd, 2024 (Chicago, IL) – Duloxetine Delayed-Release Capsules were recently recalled due to the presence of a chemical compound known as N-nitroso-duloxetine. This chemical is thought to increase the risk of cancer. The recall has been updated to a Class II, which is the second-highest risk level, as the presence of this chemical exceeds safe limits set by the FDA.

Tablets and pills.

The affected lot, as of October 17th, 2024, is Duloxetine Delayed-Release Capsules, 20mg, 500 count bottle. The lot number is 220128 with the expiry date of 12/2024. The recalled medication was manufactured by Towa Pharmaceutical in Europe and distributed nationwide in the United States. 7,100 bottles were recalled so far.

What Is Duloxetine?

Duloxetine, the generic for Cymbalta, is a medication that is used to treat ailments such as depression, anxiety, nerve pain (such as fibromyalgia or diabetic neuropathy), and chronic, long-lasting pain related to muscles and bones. It belongs to a group of medications known as SSNRIs, or selective serotonin and norepinephrine reuptake inhibitors. These medications work by increasing levels of serotonin and norepinephrine in the brain. This medication is only available via a doctor’s prescription.

What Is N-Nitroso-Duloxetine?

N-nitroso-duloxetine is a form of nitrosamine. Nitrosamines are organic compounds found in low levels in many foods we consume, as well as water. These compounds are formed via chemical reactions, and as such, can become present in medications during the manufacturing process.

Some nitrosamines may increase cancer risk if an individual is exposed to them in above-level limits. However, individuals taking medications with below or at limit nitrosamine levels are not at an increased risk of cancer.

What Does an FDA Class II Mean in Recalls?

A Class II recall refers to a product with a mid-level risk. When a product is recalled, it is assigned a level of risk. There are three levels associated with recalls. These levels are Class I: products that have the possibility of causing serious injury or death, Class II: This level has a lower chance of causing injury or death than a class I, but the possibility is still severe, and Class III: These are products that are not likely to cause adverse health issues, but there is still a chance, so the product is being recalled.

What Should I Do if I’m Taking Duloxetine?

If you are taking Duloxetine, it is important that you continue to take it, and consult with your doctor about the risks and possible alternatives to this medication. Do not stop taking duloxetine cold turkey, as the sudden decrease of this medication in your system can cause symptoms equal to or worse than the condition it was treating. It is recommended to always consult with your doctor when stopping medications.  

Side effects associated with abruptly stopping antidepressants include:

  • Increased depression or anxiety
  • Digestive issues
  • Flu-like symptoms
  • Fatigue
  • Headaches
  • Insomnia 

Can You Still File a Lawsuit if a Medication Has Been Recalled?

You can still file a lawsuit if your medication has been recalled. Recalls do not affect your ability to file a lawsuit, and companies can still be held liable for the damages you suffered due to the negligence of the pharmaceutical company. However, to file a claim, you must be able to prove that you suffered damages due to the recalled medication. An experienced product liability attorney at our Chicago injury law firm can help you understand your rights and how to file your claim.

What Damages Can You Recover?

There are a variety of losses you can recover in a medication recall lawsuit. Much like other product liability claims, you can recover compensation for past and future medical bills, lost wages, pain and suffering, mental anguish, and other medical expenses related to your injury. However, there are a few things you need to prove in order to hold an entity liable.

What Do I Need to Prove to Hold The Manufacturer Liable?

In order to hold the manufacturer liable for your losses, you need to prove the following:

  • That you were taking the medication as directed before the recall.
  • That taking the medication contributed to your injury or illness.
  • That you suffered losses due to the company’s negligence.
  • That the medication was unreasonably dangerous due to its design, the manufacturing process, or the absence of important warnings.

An attorney who is experienced in handling dangerous product claims can assist you in gathering evidence related to your claim. 

Who Can Be Held Liable in a Medication Recall Lawsuit?

Several entities, including anyone in the chain of manufacturers and distributors, can be held responsible for any damages incurred by the usage of the dangerous product. Following are examples of parties that can be held liable for your losses:

Manufacturer

The manufacturer is responsible for the creation of the product. There is an expectation that necessary steps are taken and testing is performed to ensure the safety of that product. If a manufacturer failed to adhere to these expectations, they can be held liable for any damages that incurred as a result of their negligence.

Medical Providers

If your medical provider knew the risks involved in taking these medications, failed to warn you, and prescribed them anyway, they can be held responsible for your damages. Doctors owe a duty of care to their patients, and that involves informing them of medication-related risks.

Distributors

Sometimes, if a product is stored or shipped incorrectly, it can become unsafe to use. In this instance, the distributor of the product can be held liable for patient losses.

It’s not uncommon for multiple entities to share a portion of the blame in cases like these. Your attorney can assist you in determining who to hold responsible in your defective product claim.

The experienced attorneys at Ankin Law are available to hear your case. If you took duloxetine, and you were diagnosed with cancer, contact our law firm for assistance with your case. We offer free consultations.

Chicago personal injury and workers’ compensation attorney Howard Ankin has a passion for justice and a relentless commitment to defending injured victims throughout the Chicagoland area. With decades of experience achieving justice on behalf of the people of Chicago, Howard has earned a reputation as a proven leader in and out of the courtroom. Respected by peers and clients alike, Howard’s multifaceted approach to the law and empathetic nature have secured him a spot as an influential figure in the Illinois legal system.

Years of Experience: More than 30 years
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