FDA (Drugs) recall action 99108
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.
Duloxetine Delayed-Release Capsules, USP, 60 mg, are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit. 359,676 bottles affected.
Duloxetine Delayed-Release Capsules, USP, 30 mg, in 1,000-capsule bottles are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit.