FDA (Drugs) recall action 96718
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.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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.
Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during stability testing. The affected lot was distributed nationwide.
Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during a three-month stability study under long-term storage conditions.