FDA (Drugs) recall action 88159
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.
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.
Innoveix Pharmaceuticals is recalling 728 vials of compounded Semorelin/Ipamorelin 3 mg injection due to lack of assurance of sterility. The affected lots are SIP215, SIP220, and SIP210.
Innoveix Pharmaceuticals is recalling compounded lyophilized AOD-9604 3 mg injection vials nationwide due to lack of assurance of sterility. The affected product was distributed as Rx-only injectable medication.