As many as 233,003 bottles of antidepressant Duloxetine, a prescription medication, have been recalled across the US, amid the fear of contamination with a potentially cancer-causing chemical.
The voluntary recall on November 19, initiated by Rising Pharmaceuticals, has been classified as a Class II risk by the FDA, indicating potential health risks from exposure.
The recalled drugs have now been issued a “Class II” risk level by the US Food and Drug Administration (FDA) due to the “presence of N-nitroso-duloxetine impurity above recommended interim limit.”
What is a Class II recall?
The classification as Class II is considered the second-most extreme. It is done when “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA.
What is Duloxetine
According to National Institutes of Health (NIH), Duloxetine is a medication used to manage major depressive disorder (MDD), generalized anxiety disorder (GAD), fibromyalgia, diabetic peripheral neuropathy, and chronic musculoskeletal pain. Off-label uses for duloxetine include chemotherapy-induced peripheral neuropathy and stress urinary incontinence.
According to a Newsweek report, the recalled products include the 30-count, 90-count and 1000-count bottles of 60 mg Duloxetine capsules.
For the 30-count bottles, the recalled products include:
Lot numbers DT6023059A, DT6023060A, DT6023065A, DT6023069A and DT6023070A, with an expiry date of January 2025
Lot number DT6023080A with an expiry date of February 2025
Lot number DT6023093A with an expiry date of March 2025
Lot number DTC24012A with an expiry date of December 2025
90-count bottle products include:
Lot numbers DT6023108A with expiry date April 2025
Lot number DTC23201A with expiry date Aug 2025
1000-count bottle products include:
Lot numbers DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A and DT6022173A, with expiry date November 2024
Lot numbers DT6023009A, DT6023007A, DT6023008A, DT6023011A and DT6023034B, with expiry date December 2024
Lot number DT6023067C with expiry date January 2025
Lot number DT6023114A with expiry date April 2025
Lot number DTC23243A with expiry date October 2025
Lot number DTC24040A with expiry date December 2025
What are N-nitroso compounds
N-nitroso compounds are chemicals called nitrosamines. They are chemical contaminants formed during the processing and manufacture of certain foods such as bacon, cheese, cured meat and fish. N-nitroso-duloxetine is a specific type of N-nitroso compound that can form during the manufacturing or storage process of duloxetine.
Products containing levels of N-nitroso-duloxetine impurities above the recommended interim limit are dangerous as they are classified as potential carcinogens.
Exposure to N-nitroso compounds beyond acceptable limits can raise long-term health risks.
In a previous instance, a batch of duloxetine produced by another company, Towa Pharmaceutical Europe, was recalled in October.
“There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA said in a statement at the time.
“As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.”
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