Duloxetine recall: What patients should check before changing medication
The recall involves certain generic duloxetine delayed-release capsules distributed nationwide. Patients should check their bottle and contact a pharmacist or prescriber before making medication chang
by Brandon Burley and The Redemption Project
A recall involving certain bottles of generic duloxetine delayed-release capsules has raised questions for patients who take the medication for depression, anxiety, nerve pain and other conditions.
The most important guidance is practical: check the bottle, call the pharmacy and do not stop the medication abruptly without medical guidance.
The recall does not affect every duloxetine prescription. It involves specific lots of duloxetine delayed-release capsules, USP, in 30 mg and 60 mg strengths. Duloxetine is the generic form of the medication commonly known by the brand name Cymbalta.
The affected medication was manufactured by Towa Pharmaceutical Europe, S.L., and distributed in the United States by Breckenridge Pharmaceutical, Inc., according to FDA-related recall records and current public reporting.
The recall was issued because some products may contain N-nitroso-duloxetine, a nitrosamine impurity, above the Food and Drug Administration’s recommended limit.
Nitrosamines are impurities that can be found in some medications. The FDA says nitrosamines are also found in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines.
