Tranexamic Acid Tablet
FDA Recall NDC 69918-301
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 69918-301). A significant event, classified as Class III, was initiated on Jun 12, 2023 by Nordic Pharma, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Jun 12, 2023
Jun 21, 2023
48,989 bottles
Recall Profile & Regulatory Data
Event ID
92458
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Amring Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
May 29, 2024
Product Description
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
Batch or Lot Expiration Information
Lot# Lots: X220317A and X220318A, exp. date 09/25
Affected Packages Involved in this Recall
69918-301-30Product
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.
