Milan Institutional LLC is recalling a heart drug and a hemophilia medicine distributed to hospitals and medical clinics after a packaging blunder swapped the labels of the two products.

Milan said that certain vials of Aminodarone HCl injection and Tranexamic Acid Injection are being recalled because cartons labeled as Tranexamic Acid Injection may contain vials of Amiodarone HCl injection, and vice-versa. Both of these medications are administered in hospital settings only by trained health care professionals.

Amiodarone HCl is used to treat heart rhythm problems. If someone is inadvertently administered Amiodarone, they may experience low blood pressure and irregular heart rhythms, including a very low heart rate, which could have immediate life-threatening effects on cardiac function. And, if treatment with Amiodarone is delayed for a patient who needs it, it could result in continued irregular heartbeat and the potential for life-threatening effects on cardiac function as well.

Tranexamic Acid is used to treat hemophilia and other blood clotting problems, such as heavy bleeding during menstrual periods for women. If it is inadvertently administered to someone, it could cause blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid is delayed, it could cause potentially life-threatening bleeding events.

To date, Mylan has not received any adverse events related to this recall.

Affected products were distributed between April 2020 and July 2020. Mylan is notifying its wholesalers, hospitals, and clinics about the packaging mistake and arranging for the return of the products.

Anyone who believes they have suffered ill effects due to this recall should file a report with the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting program.

This is Mylan’s third product recall this year. In January, the company recalled the heartburn drug nizatidine after discovering it contained a likely carcinogen, N-Nitrosodimethylamine (NDMA). Nizatidine is in the same family of medicines as ranitidine, the active ingredient in the acid reflux medicine Zantac, which was pulled from the market in April due to NDMA contamination. Beasley Allen lawyer Frank Woodson is handling claims related to the Zantac recall.

In July, Mylan recalled daptomycin, used to treat serious skin infections caused by bacteria, after the company found vials to contain particulate matter and, if injected, could cause patients to suffer local irritation, microvascular obstruction, allergic reactions and other problems.


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