FDA (Drugs) recall action 95853
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.