FDA (Drugs) recall action 94483
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
The agency’s own wording, quoted from the enforcement report.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.
Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.