FDA (Drugs) recall action 96325
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.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
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.
Amgen is recalling Neupogen (filgrastim) injectable vials due to stability concerns. Stability data indicates the product may be out of specification at its expiration date.
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.