FDA (Drugs) recall action 84006
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Lack of Sterility Assurance.
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 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units due to a lack of sterility assurance.
Innoveix Pharmaceuticals is recalling 413 vials of Lyophilized Human Chorionic Gonadotropin 5,000 USP Units due to a lack of sterility assurance.
Innoveix Pharmaceuticals is recalling 3,905 vials of Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection due to a lack of sterility assurance.
Innoveix Pharmaceuticals is recalling 1,747 vials of compounded Sermorelin injection because the product lacks sterility assurance.