FDA (Drugs) recall action 98034
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 the FDA recommended 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.
Philips North America is recalling the IntelliVue Patient Monitor MX550 over a potential issue where the monitors did not alarm.
Breckenridge Pharmaceutical is recalling 7,389 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended limit.