Medications & Supplements/Prescription Drugs

Pfizer Inc.: Argatroban Injection Recalled for Impurity and Stability Issues

Agency Publication Date: September 7, 2018

Summary

Pfizer Inc. is recalling 1,580 vials of Argatroban Injection, 250 mg/2.5 mL (100 mg/mL). This prescription blood thinner (anticoagulant) is being recalled because routine stability testing at the 18-month mark showed that the medication did not meet required specifications for impurities and degradation. This means the drug may break down faster than expected, potentially affecting its quality and safety over time.

Risk

The presence of impurities or degradation products beyond established limits could potentially lead to reduced drug effectiveness or unexpected side effects, though the risk is currently categorized as low.

What You Should Do

Identify your medication by checking the label for Argatroban Injection, 250 mg/2.5 mL (100 mg/mL) in a 2.5 mL single-use vial with NDC 0409-1140-01.
Check the physical vial or packaging for lot number DP602 with an expiration date of 10/2018.
If you have an affected vial, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.
Return any unused product from this specific lot to your pharmacy for a refund and contact Pfizer at 1-800-438-1985 for further instructions regarding the return process.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial

Model:

NDC: 0409-1140-01

Lot Numbers:

DP602

Date Ranges: 10/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80923

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc

Manufactured In: United States

Units Affected: 1,580 vials

Distributed To: Nationwide

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

Identify your medication by checking the label for Argatroban Injection, 250 mg/2.5 mL (100 mg/mL) in a 2.5 mL single-use vial with NDC 0409-1140-01.

Check the physical vial or packaging for lot number DP602 with an expiration date of 10/2018.

If you have an affected vial, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.

Return any unused product from this specific lot to your pharmacy for a refund and contact Pfizer at 1-800-438-1985 for further instructions regarding the return process.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).