AuroMedics Fondaparinux Injection Recall: Subpotent Drug Risk

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Contact the company & request your remedy

Recalling firmAuroMedics Pharma LLC279 Princeton Hightstown Rd, N/A · East Windsor, NJ 08520-1401

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

AuroMedics recalls a specific blood thinner injection because it may not contain enough active ingredient. This could lead to ineffective blood thinning, increasing clotting risks. The recall covers certain lots made in India with specific NDC numbers.

Why it’s dangerous

The injection may have lower than expected active drug levels. This could result in the medication not working properly to prevent blood clots, potentially leading to clot formation in some patients.

Who’s affected

Patients using this blood thinner injection for anticoagulation therapy. Those with the specific NDC numbers and lot numbers listed are most at risk.

How to tell if you have this one

Check the NDC code on the carton (55150-232-10) or syringe (55150-232-00). The lot number CFN200020 with expiration date November 2022 is affected.

Brand
AuroMedics
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for NDC 55150-232-10 on the carton or 55150-232-00 on the syringe, and lot number CFN200020.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the product may have subpotent drug levels, meaning it might not work as intended. Do not use until confirmed safe.

What should I do if I have this product?

Check the NDC and lot number. If it matches the recalled items, contact your healthcare provider for guidance.

How can I confirm if my product is recalled?

Look for NDC 55150-232-10 (carton) or 55150-232-00 (syringe) with lot number CFN200020.

Take action

Contact AuroMedics

We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0020-2023 — AuroMedics AuroMedics

Hello,

I own a AuroMedics that is covered by recall D-0020-2023 from AuroMedics.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0020-2023 (September 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0020-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics

Lower-risk recall