The FDA recalls over 7,000 bottles of an antidepressant due to a potentially harmful chemical
“Patients are advised to consult their healthcare providers regarding any concerns and explore alternative treatment options,” states the FDA’s website.
The Food and Drug Administration has issued a Class II recall for over 7,000 bottles of an antidepressant due to the detection of a harmful chemical.
The recall was first announced on October 10.
Duloxetine, commonly known as Cymbalta among other brand names, is prescribed for various mental health conditions, including anxiety and depression, as stated by the Cleveland Clinic. This medication was distributed nationwide and produced by Towa Pharmaceutical Europe.
The FDA indicated that the drug contained a problematic impurity called N-nitroso-duloxetine.
The agency warned that nitrosamine impurities “might elevate the risk of cancer if people are exposed above acceptable levels and for extended periods.”
Nonetheless, the FDA clarified, “a person using a medication with nitrosamines within the daily intake limits for 70 years is not likely to have an increased cancer risk.”
Here’s what we know regarding the recall:
How many bottles are affected by the recall?
The recall notice mentions that 7,107 bottles were affected, which includes delayed-release capsules in 500-count bottles.
The recall is classified as Class II, meaning that exposure could lead to “temporary or medically reversible adverse health effects,” according to the FDA.
Which batch of the medication is involved in the recall?
The recalled batch number is #220128, which is set to expire in December 2024.
What should individuals do if their medication is recalled?
Officials recommend that anyone possessing medications that may contain nitrosamines should stop using them.
“Patients should consult their healthcare providers about any concerns and explore other treatment options,” the FDA’s website advises.
What are nitrosamines?
Nitrosamines can be present in water, processed meats, grilled foods, dairy, and vegetables, as noted by the FDA. While most people are exposed to small amounts of nitrosamines, research suggests that long-term exposure to high levels increases the risk of cancer.
Since 2018, over 12 million bottles of blood pressure medications like valsartan and losartan have been recalled due to nitrosamines.
These same contaminants have previously led to recalls of the heartburn medication Zantac, the diabetes drug metformin, and the smoking cessation drug Chantix.
This article has been updated to correct a spelling error.
