AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics
Recalled October 12, 2022 · FDA recall D-1551-2022 · AuroMedics Pharma
Hazard
Presence of Particulate Matter: Piece of metal found in a vial · FDA Class III
Units
88080 vials
Sold at
Distributed Nationwide in the USA
Description
Presence of Particulate Matter: Piece of metal found in a vial
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
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →