Medications & Supplements/Prescription Drugs

Heparin Sodium Injection Recalled for Labeling Issue

Agency Publication Date: March 6, 2023

Summary

Sagent Pharmaceuticals Inc has recalled 28,875 vials of Heparin Sodium Injection, USP (20,000 USP units per mL). This recall was initiated due to a labeling issue that could potentially lead to medication errors. No incidents or injuries have been reported to date. This medication is typically used in hospitals, clinics, and through pharmacies for intravenous or subcutaneous use.

Risk

Incorrect or inadequate labeling on high-potency heparin vials can lead to healthcare providers or patients administering the wrong dose. Such errors could result in serious adverse health consequences, including major bleeding or other complications.

What You Should Do

This recall affects Heparin Sodium Injection, USP (20,000 USP units per mL) packaged in 25 x 1 mL multi-dose vials under the Sagent Pharmaceuticals brand (NDC 25021-404-01). Affected products are labeled with lot number WP201 and an expiration date of February 2024.
Identify affected products by checking the lot number WP201 (Exp 2/2024) printed on the vial or carton.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sagent Pharmaceuticals Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Heparin Sodium Injection, USP, 25 x 1 mL Multi-Dose Vialsby Sagent Pharmaceuticals

Variants: 20,000 USP units per mL, For Intravenous or Subcutaneous Use

Lot Numbers:

WP201 (Exp 2/2024)

NDC:

25021-404-01

Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91789

Status: Resolved

Manufacturer: Sagent Pharmaceuticals Inc

Sold By: hospitals; clinics; pharmacies

Manufactured In: India, United States

Units Affected: 28,875 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Heparin Sodium Injection, USP (20,000 USP units per mL) packaged in 25 x 1 mL multi-dose vials under the Sagent Pharmaceuticals brand (NDC 25021-404-01). Affected products are labeled with lot number WP201 and an expiration date of February 2024.

Identify affected products by checking the lot number WP201 (Exp 2/2024) printed on the vial or carton.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sagent Pharmaceuticals Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.