The FDA announced a recall on Oct. 23 of thousands of bottles of the popular antidepressant Cymbalta due to a possible cancer risk, according to USA Today.
Cymbalta is used to treat mental health conditions such as depression and anxiety.
The agency recalled more than 7,000 bottles of the drug duloxetine, brand name Cymbalta, which is manufactured by Eli Lilly & Company. The recalled lot, #220128, was manufactured by Towa Pharmaceutical Europe and was sold across the U.S. The recall is for 20-mg delayed-release capsules which expire in December 2024.
The FDA issued the recall due to the presence of a nitrosamine substance impurity, N-nitroso-duloxetine. Nitrosamines are found in water, grilled meat and even vegetables and are harmless in trace amounts.
Drugs can develop nitrosamine impurities during the manufacturing process.
According to the FDA, “nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
The FDA advises patients with this recalled medication to stop taking it and contact their health care provider.
There have been several other drug recalls in recent years linked to nitrosamine impurities including the heartburn drug famotidine (Zantac; Sanofi), the diabetes drug metformin (Fortamet; Ajanta Pharma), and the smoking cessation medication varenicline (Chantix; Pfizer), according to Pharmacy Times.
