FDA (Drugs) recall action 84240
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Crystallization: Presence of visible particulate matter.
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.
AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.
AuroMedics Pharma LLC is recalling 28,810 vials of Amiodarone Hydrochloride Injection due to the presence of visible particulate matter.
AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.