Amiodarone HCl Injection and Tranexamic Acid Injection Recall

FDA – September 1, 2020 – According to an FDA Safety Alert, Mylan Institutional LLC is recalling four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, and Tranexamic Acid Injection, USP 1000 mg/10 mL. Both are hospital/clinic level medications. In some of the lots being recalled, a few of the cartons containing Tranexamic Acid Injection, USP contain some vials of Amiodarone HCl Injection. Also, some of the cartons of labeled as Amiodarone HCl Injection contain vials of Tranexamic Acid Injection, USP. The individual vials contained in the boxes are labeled correctly. The FDA states that these medications are only given in a hospital setting.

Tranexamic Acid Injection, USP, and Amiodarone HCl Injection, USP are different medications, and these medications treat different medical conditions. A patient given the incorrect medication is at significant risk for sustaining a severe injury or death due to sustained irregular heartbeats, seizures, hypersensitivity reactions, a dangerous drop in blood pressure, blood clots, visual disorders, and potentially life-threatening cardiac disfunction. Also, if a patient needs to receive their treatment of a Tranexamic Acid Injection, and this is delayed due to receiving the incorrect medication, the patient could suffer severe and life-threatening bleeding episodes.

Amiodarone HCl Injection, USP, an antiarrhythmic medication that provides prophylaxis (protection from) recurring episodes of ventricular fibrillation (VF) and prevents episodes of hemodynamically unstable ventricular tachycardia (VT) when a patient, who suffers from certain heart conditions, is about to undergo certain types of medical procedures or therapies.

Tranexamic acid medications are administered to patients who have bleeding disorders such as hemophilia and are only used prior to a surgical procedure such as a tooth extraction to reduce or prevent hemorrhage and reduce the need for replacement therapy.

The recalled batches were distributed to wholesalers and hospital/clinical pharmacies throughout the United States beginning April 2020 to July 2020. The following recalled batch information is as follows:

NDC # 67457-153-09 Amiodarone HCl Injection, USP 450 mg/9 mL 10 x 9 mL single-dose vials 191207 Exp. Nov. 2021, 191221 Exp. Nov. 2021, 191223, Exp. Nov. 2021, 200120 Exp. Dec. 2021

NDC # 67457-197-10 Tranexamic Acid Injection, USP 1000 mg/10 mL 10 x 10 mL single-dose vials

Mylan will be cautioning its hospital/clinic pharmacy clients and drug wholesalers by letter. The company is managing the return of these recalled medications to Stericycle. Hospital/clinic pharmacies and medical wholesalers are being asked to stop using, distributing, or dispensing the recalled medications.

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