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Towa Pharmaceutical Europe has recalled 7,107 bottles of duloxetine delayed-release capsules due to elevated levels of a cancer-causing chemical, N-nitroso-duloxetine, a nitrosamine impurity. The FDA assigned this a Class II recall classification, affecting 500-count bottles of 20 mg duloxetine delayed-release capsules expiring in December 2024.
Key Points:
- The recall impacts lot number 220128 (NDC: 51991-746-05) due to manufacturing practice deviations and nitrosamine levels above interim limits
- FDA classifies this as Class II recall, indicating potential temporary or medically reversible health consequences
- Patients should not discontinue medication without consulting healthcare providers, as benefits currently outweigh risks
- Healthcare providers can verify affected lot numbers with pharmacies and report adverse events to FDA
- Alternative treatments include other antidepressants, natural remedies, and for fibromyalgia specifically, movement therapy and anti-inflammatory diet
“The chemicals found in duloxetine put patients at a higher risk of developing cancer when they are present in higher concentrations and when patients are exposed to them for an extended period of time.”
– David Cosio, PhD, ABPP, Psychologist, Jesse Brown VA Medical Center in Chicago
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