WASHINGTON — Thousands of bottles of a widely used antidepressant, duloxetine, are being voluntarily recalled due to the presence of a potentially toxic chemical, according to a notice from the U.S. Food and Drug Administration (FDA).
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The recall, initiated on October 10, involves duloxetine, which is sold under the brand name Cymbalta, and is used to treat anxiety, depression, and other mood disorders. The FDA’s recall notice highlights concerns over the presence of N-nitroso duloxetine, a chemical compound that, in elevated concentrations, could pose health risks.
Here are three essential points for consumers to know about the recall.
1. How to Determine if Your Medication is Affected
The recall targets 7,101 bottles of duloxetine delayed-release capsules, which were distributed across the United States. The affected capsules are 20mg in strength and sold in 500-count bottles.
To identify if your medication is part of the recall, check the lot number. The recalled capsules are from lot number 220128 with an expiration date of December 2024, according to the FDA notice.
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The capsules were manufactured by Towa Pharmaceutical Europe. In response to the recall, Towa Pharmaceutical Europe directed consumers to the FDA’s guidance on nitrosamine impurities in medications.
2. The Toxic Chemical Behind the Recall
The recall was triggered due to higher-than-allowed levels of N-nitroso duloxetine, a chemical that, if consumed in large amounts, may be toxic and is suspected to have cancer-causing properties, according to the U.S. National Library of Medicine.
The FDA classified this as a Class II recall, indicating that exposure to the product may lead to temporary or medically reversible adverse health consequences, though the risk of serious harm is considered remote.
3. What to Do if Your Medication is Recalled
The FDA’s recall notice does not provide specific instructions for handling recalled duloxetine capsules. However, because of the potential health risks, it is crucial to consult a healthcare professional before stopping or altering the use of any antidepressant medication.
The FDA continues to investigate the source of the contamination and will provide updates as more information becomes available.
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For more details on the recall and the potential risks associated with nitrosamine impurities, patients are advised to visit the FDA’s website or contact their healthcare provider.
