Drugplain

CLOFARABINE 1 mg/mL

CLOFARABINE · INJECTION · Eugia US LLC

2 Recalls on Record
Plain English

CLOFARABINE is a injection containing clofarabine at 1 mg/mL, taken intravenous. Manufactured by Eugia US LLC.

Key Facts

Brand Name
CLOFARABINE
Generic Name
CLOFARABINE
NDC Code (Product)
55150-326
Manufacturer
Eugia US LLC
Strength
1 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA212457
Drug Class
Nucleoside Metabolic Inhibitor [EPC]
Marketing Start
10/03/2022

Recall History

2 Recalls on Record
Class III10/13/2017

Sanofi-Aventis U.S. LLC

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

TerminatedVoluntary: Firm initiated
Class III10/12/2017

Genzyme Corporation

Labeling: Incorrect or Missing Package Insert.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is CLOFARABINE used for?

CLOFARABINE contains CLOFARABINE. It is a injection taken intravenous. Consult your doctor for specific uses.

Is CLOFARABINE a controlled substance?

CLOFARABINE is not classified as a controlled substance by the DEA.

What is the generic name for CLOFARABINE?

The generic name for CLOFARABINE is CLOFARABINE. There are 5 other brand versions of CLOFARABINE.

What is the NDC code for CLOFARABINE 1 mg/mL?

The NDC (National Drug Code) for CLOFARABINE 1 mg/mL is 55150-326, listed by Eugia US LLC.

Product NDC

55150-326

Package NDC

55150-326-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)