Tranexamic Acid Injection, Solution
FDA Recall NDC 55150-188
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tranexamic Acid (NDC 55150-188). A significant event, classified as Class III, was initiated on Sep 26, 2022 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter: Piece of metal found in a vial"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Presence of Particulate Matter: Piece of metal found in a vial
Sep 26, 2022
Oct 12, 2022
88080 vials
Recall Profile & Regulatory Data
Event ID
90897
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: CTA210006, Exp. 02/2024
Affected Packages Involved in this Recall
55150-188-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
