Product: Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Reason for recall: Presence of Particulate Matter: Piece of metal found in a vial
Recall initiated: 20220926
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated