Medications & Supplements/Prescription Drugs

Fresenius Kabi USA, LLC: Fluorouracil Injection Recalled for Presence of Glass Particulates

Agency Publication Date: July 17, 2019

Summary

Fresenius Kabi USA, LLC has recalled 14,016 vials of Fluorouracil Injection, USP (5 g / 100 mL), a prescription medication used in cancer treatment. This recall affects both the Fresenius Kabi brand and the NOVAPLUS brand due to the presence of visible glass particulate matter found in the vials. Consumers should be aware that using an injectable drug containing glass particles can lead to serious health complications, such as inflammation or damage to blood vessels and vital organs. You should contact your healthcare provider or pharmacist immediately if you have received this medication.

Risk

The injection of glass particulates can cause local irritation, inflammation, or the blockage of blood vessels, which may lead to serious events like pulmonary embolism or damage to organs such as the heart and kidneys.

What You Should Do

Check your medication vials for Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL) in 100 mL vials.
Identify if you have the Fresenius Kabi brand (NDC 63323-117-61) with Lot number 6120420 and Product Code 101761.
Identify if you have the NOVAPLUS brand (NDC 63323-117-69) with Lot number 6120341 and Product Code NP101761.
If you have an affected lot, do not use the medication; contact your healthcare provider or pharmacist immediately for guidance on alternatives.
Return any unused product from these specific lots to the pharmacy where it was dispensed for a refund.
Contact Fresenius Kabi USA, LLC directly for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall baseline remedy

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

Affected Products

Product: Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial [Fresenius Kabi brand]

Model:

101761

UPC Codes:

6332311761

Lot Numbers:

6120420

Product: Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial [NOVAPLUS brand]

Model:

NP101761

UPC Codes:

6332311769

Lot Numbers:

6120341

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83234

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Manufactured In: United States

Units Affected: 14,016 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

Check your medication vials for Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL) in 100 mL vials.

Identify if you have the Fresenius Kabi brand (NDC 63323-117-61) with Lot number 6120420 and Product Code 101761.

Identify if you have the NOVAPLUS brand (NDC 63323-117-69) with Lot number 6120341 and Product Code NP101761.

If you have an affected lot, do not use the medication; contact your healthcare provider or pharmacist immediately for guidance on alternatives.

Return any unused product from these specific lots to the pharmacy where it was dispensed for a refund.

Contact Fresenius Kabi USA, LLC directly for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial [Fresenius Kabi brand]

Model:

101761

UPC Codes:

6332311761

Lot Numbers:

6120420

Product: Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial [NOVAPLUS brand]

Model:

NP101761

UPC Codes:

6332311769

Lot Numbers:

6120341