Tranexamic Acid Tablet
FDA Recall NDC 50268-772
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 50268-772). A significant event, classified as Class III, was initiated on Jun 13, 2023 by Avpak. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity."
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
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Jun 13, 2023
Jun 21, 2023
592 cartons
Recall Profile & Regulatory Data
Event ID
92535
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AVKARE LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Batch or Lot Expiration Information
Lot# Lot: 44286 Exp. 02/2025
Affected Packages Involved in this Recall
50268-772-11Product
50268-772-13Product
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.
