FDA Recalled Thousands of Duloxetine Bottles Over Impurity — Drug Recall
Thousands of bottles of the antidepressant duloxetine were pulled in a drug recall after testing found levels of N-nitroso-duloxetine above federal safety limits. The voluntary action involved products made by Towa Pharmaceutical and distributed by Breckenridge Pharmaceutical Inc.
The recall was classified as a Class II recall. The FDA says that level means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
FDA limits and duloxetine
Duloxetine is a prescription medication used to treat depression and anxiety. The FDA says nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.
The agency also says people exposed to these impurities at or below the acceptable daily intake limit are not expected to have an increased risk of cancer. N-nitroso-duloxetine belongs to a class of compounds known as nitrosamines, and some nitrosamines are considered probable human carcinogens.
Towa Pharmaceutical and Breckenridge
The recall was issued because the impurity was found at levels that exceed the FDA's recommended limit. The action covers thousands of bottles, making this a broader quality issue than a single lot or isolated package.
The FDA notice said the impurity, above the recommended limit, triggered the recall under its safety rules. There is no specific evidence linking N-nitroso-duloxetine directly to cancer, and health risks tied to these substances generally depend on the amount and duration of exposure.
Class II recall
For patients who take duloxetine, the practical issue is the product already in hand. The recall classification places it below the FDA's most serious category, but the agency still treats exposure to the product as one that may cause temporary or medically reversible effects.
That leaves the key decision with the manufacturer and distributor: remove the affected bottles from circulation while the impurity issue is addressed. Anyone using recalled duloxetine products will need to follow the recall notice tied to their specific bottle and lot information.
