Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Tranexamic Acid Injection Recalled by AuroMedics Pharma LLC Due to Presence of Particulate Matter: Piece of metal found...

Date: September 26, 2022
Company: AuroMedics Pharma LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AuroMedics Pharma LLC directly.

Affected Products

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

Quantity: 88080 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AuroMedics Pharma LLC

AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report