FDA (Drugs) recall action 97110
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
CGMP Deviations; potential temperature excursions due to transit delays
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.
Prolia (denosumab) injection 60 mg/mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 6 pre-filled syringes are affected.
Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 2 pre-filled syringes affected.
Benlysta (belimumab) for injection 400 mg/20 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 3 vials are affected.