FDA recall D-1551-2022

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

Distribution

Distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2022-09-26

Report date

2022-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1551-2022