FDA (Drugs) recall action 97808
The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.
Lack of Assurance of Sterility
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.
ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.
ProRx is recalling 8,400 vials of Semaglutide Injection 10 mg/4 mL for lack of assurance of sterility.
ProRx is recalling 2,649 vials of Semaglutide Injection 2.5 mg/1 mL from one lot for lack of assurance of sterility.
ProRx is recalling 11,119 vials of Semaglutide Injection 8 mg/3.2 mL across four lots for lack of assurance of sterility.
ProRx is recalling 8,310 vials of Semaglutide Injection 6 mg/2.4 mL across three lots for lack of assurance of sterility.
ProRx is recalling 2,761 vials of Tirzepatide Injection 27 mg/3 mL from one lot for lack of assurance of sterility.
ProRx is recalling 2,809 vials of Semaglutide Injection 12.5 mg/5 mL from one lot for lack of assurance of sterility.