The Food and Drug Administration has issued a Class II recall for thousands of bottles of duloxetine, the generic version of the antidepressant Cymbalta, due to contamination with a potentially carcinogenic chemical. The October 10 recall affects 7,107 bottles of the medication manufactured by Towa Pharmaceutical Europe and distributed nationally throughout the United States.
Contamination Details
The recalled duloxetine contains N-nitroso-duloxetine, a chemical that is toxic if swallowed and suspected of causing cancer, according to the National Library of Medicine. The FDA classified this as a Class II recall, indicating the drug could cause "temporary or medically reversible adverse health consequences."
The specific products affected include 500-count bottles of delayed-release 20mg capsules with lot number 220128 and an expiration date of December 2024. The recall was initiated by Breckenridge Pharmaceutical, Inc., which distributed the medication manufactured by Towa Pharmaceutical Europe.
Nitrosamine Contamination Context
The contamination involves nitrosamine, a class of chemicals found in trace amounts throughout the environment in food, water, and medications. However, these chemicals are considered unsafe above certain thresholds, particularly when consumed over extended periods. The FDA has been working with international health agencies to establish "internationally recognized acceptable daily intake limits" for these substances.
This recall represents part of a broader trend of increased testing by the FDA to ensure medications meet safer thresholds and to reduce or eliminate nitrosamines from man-made sources like pharmaceuticals.
Patient Safety Recommendations
The FDA recommends that patients consult with their healthcare professionals about the best course of action if they possess recalled medication. Importantly, both the FDA and Towa Pharmaceutical emphasize that patients taking prescriptions "with potential nitrosamine impurities should not stop taking their medications" without medical supervision.
Healthcare experts warn that people taking duloxetine shouldn't suddenly discontinue the medication due to the risk of adverse reactions. Patients with questions about the recall can contact Qualanex, which is handling the recall on behalf of Breckenridge Pharmaceutical, at 1-877-857-1145 or 1-877-878-0504.
Brand Name Cymbalta Unaffected
While duloxetine is the generic version of Cymbalta, the brand-name medication manufactured by Eli Lilly is not included in this recall. An Eli Lilly spokesperson confirmed that Cymbalta is "not affected and it is not the product being recalled."
About Duloxetine
Duloxetine belongs to a class of drugs called SNRIs (serotonin-norepinephrine reuptake inhibitors) and is used to treat depression, anxiety, fibromyalgia, and chronic pain. The medication works by increasing serotonin and norepinephrine levels in the brain, which help regulate mood and pain.
Patients prescribed any form of duloxetine are advised to check the recall details to determine if their medication matches the recalled lot number and manufacturer specifications before taking any action regarding their treatment.
