FDA (Drugs) recall action 70564
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; due to leaking vials
The agency’s own wording, quoted from the enforcement report.
Mylan Institutional LLC is recalling Haloperidol Decanoate Injection because leaking vials raised concerns about the product's sterility.
Mylan Institutional LLC is recalling specific lots of Haloperidol Decanoate Injection due to leaking vials that compromise sterility assurance.