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By Jess Thomson
Science Reporter
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A commonly prescribed antidepressant has been recalled across the U.S. due to fears of contamination with a potentially cancer-causing chemical.
233,003 bottles of the drug, named Duloxetine, were voluntarily recalled by their distributor, Rising Pharmaceuticals, Inc.—based in East Brunswick, New Jersey—on November 19.
The recall was voluntarily initiated by the firm due to the "presence of N-nitroso-duloxetine impurity above recommended interim limit."
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The recalled drugs have now been issued a "Class II" risk level by the U.S. Food and Drug Administration (FDA).
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A Class II recall is the second-most extreme, and is given 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.
Duloxetine is a prescription medication that belongs to the class of drugs called serotonin-norepinephrine reuptake inhibitors (SNRIs). It is commonly used to treat a variety of conditions, including depression, anxiety, and nerve pain like fibromyalgia.
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
Newsweek has contacted Rising Pharmaceuticals for comment.
N-nitroso compounds are chemicals called nitrosamines. 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 because N-nitroso compounds are classified as potential carcinogens.
Regulatory agencies like the FDA and European Medicines Agency (EMA) have strict guidelines for allowable levels of N-nitroso compounds in pharmaceuticals. Exposure to levels above the interim acceptable daily intake limits poses potential long-term health risks, especially with prolonged use.
A batch of duloxetine produced by another company, Towa Pharmaceutical Europe, was also 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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