FDA Drug · D-1576-2020

Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Class I · Terminated

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.

Affected lots / codes — check yours against thisLot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021

Recalling firm: Mylan Institutional LLC, Rockford, IL
Classification: Class I (most serious — risk of serious harm)
Status: Terminated
Quantity: 1407 cartons
Distribution: Nationwide
Recall initiated: August 17, 2020
Classified: September 11, 2020
Terminated: December 28, 2022
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1576-2020%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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