FDA recalls 233K bottles of antidepressants due to cancer risk
Bottles of duloxetine manufactured by Rising Pharmaceuticals are being pulled due to higher-than-normal levels of nitrosamine contaminants. The recall is classified as a Schedule II, the second most serious type.
The U.S. Food and Drug Administration (FDA) has recalled more than 233,000 bottles of duloxetine, an antidepressant, due to the presence of nitrosamine, a carcinogenic chemical. The recall has been designated as Class II, the second most serious classification.
The recall was first initiated on Nov. 5 by the manufacturer, Rising Pharmaceuticals.
The FDA stated that nitrosamine increases the risk of cancer over time when it exceeds a safe threshold. No increased risk of cancer is observed when patients are exposed to nitrosamine impurities at safe levels.
Nitrosamine is found in tap water, meat, dairy products, and vegetables. The FDA noted that everyone is exposed to trace amounts and that some exposure is normal, even in pharmaceuticals.
"[A] person taking a drug that contains nitrosamines at or below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA said.
This is the second recall of duloxetine this year. In October, 7,107 bottles of duloxetine manufactured by Towa Pharmaceutical Europe were recalled, also due to high levels of nitrosamines.
What is being recalled?
Duloxetine DR Capsules, USP 60 mg, manufactured by Rising Pharmaceuticals with delayed release, are subject to the recall. This includes:
- 30-count (NDC 57237-019-30) bottles
- 90-count (NDC 57237-019-90) bottles
- 1,000-count (NDC 57237-019-99) bottles
Next Steps
The FDA and Rising Pharmaceuticals recommend that patients stop taking the recalled duloxetine immediately and seek a new prescription. Pharmacies have been alerted about the recall and are no longer distributing the recalled pills.
The full recall notice can be found here.
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