FDA (Drugs) recall action 84534
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.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
The agency’s own wording, quoted from the enforcement report.
Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.
Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.