Heparin Sodium Injection
FDA Recall NDC 25021-404
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 Heparin Sodium (NDC 25021-404). A significant event, classified as Class II, was initiated on Feb 28, 2023 by Sagent Pharmaceuticals. The reported reason for this action was: "Labeling: Not elsewhere classified"
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 II Terminated
Labeling: Not elsewhere classified
Feb 28, 2023
Mar 15, 2023
28,875 vials
Recall Profile & Regulatory Data
Event ID
91789
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sagent Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
May 19, 2026
Product Description
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
Batch or Lot Expiration Information
Lot# : WP201, Exp 2/2024
Affected Packages Involved in this Recall
25021-404-01Product
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.
