Medications & Supplements/Prescription Drugs

Fondaparinux Sodium Injection Recalled for Subpotency

Agency Publication Date: October 24, 2022

Summary

AuroMedics Pharma LLC is recalling 11,520 units of Fondaparinux Sodium Injection (7.5 mg per 0.6 mL) because the medication was found to be subpotent, meaning it did not meet strength specifications. This injectable blood thinner is used to treat and prevent blood clots in the legs and lungs. While no injuries have been reported, a subpotent drug may not provide the full therapeutic effect needed to prevent dangerous clotting events.

Risk

The drug is subpotent, which means patients may receive a lower dose of medication than intended. This could lead to inadequate prevention or treatment of blood clots, increasing the risk of serious medical complications like deep vein thrombosis or pulmonary embolism.

What You Should Do

The recalled products are single-dose prefilled syringes of Fondaparinux Sodium Injection, USP (7.5 mg per 0.6 mL) with NDC 55150-232-10 on the carton and NDC 55150-232-00 on the individual syringe.
Check your medication for lot number CFN200020 with an expiration date of November 2022.
If you have health concerns or are currently using this medication, contact your healthcare provider or pharmacist immediately for guidance.
Return any unused product to the place of purchase for a refund, throw it away, or contact AuroMedics Pharma LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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: Fondaparinux Sodium Injection, USP (7.5 mg per 0.6 mL)

Variants: 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe

Lot Numbers:

CFN200020 (Exp Nov. 2022)

NDC:

55150-232-10

55150-232-00

Distributed by AuroMedics Pharma LLC; manufactured in India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90925

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: hospitals; pharmacies

Manufactured In: India, United States

Units Affected: 11,520 units

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

The recalled products are single-dose prefilled syringes of Fondaparinux Sodium Injection, USP (7.5 mg per 0.6 mL) with NDC 55150-232-10 on the carton and NDC 55150-232-00 on the individual syringe.

Check your medication for lot number CFN200020 with an expiration date of November 2022.

If you have health concerns or are currently using this medication, contact your healthcare provider or pharmacist immediately for guidance.

Return any unused product to the place of purchase for a refund, throw it away, or contact AuroMedics Pharma LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.