FDA (Drugs) recall action 86247
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.
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
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.
Mylan Institutional LLC is recalling 1,407 cartons of Tranexamic Acid Injection due to a labeling error that may result in the wrong medication being dispensed.
Mylan Institutional LLC is recalling Amiodarone Hydrochloride Injection due to a labeling error where cartons may contain the wrong medication.