Recall: D-1551-2022

Class III - Minor Violations

Class IIIClassification

2022-09-26Initiated

OngoingStatus

AuroMedics Pharma LLCFirm

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

Presence of Particulate Matter: Piece of metal found in a vial

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.