Drugplain

Oxaliplatin 50 mg/10mL

Oxaliplatin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Gland Pharma Limited

4 Recalls on RecordCurrently in Shortage
Plain English

Oxaliplatin is a platinum-based chemotherapy medication given by intravenous injection used to treat colorectal cancer and other cancers. It works by damaging cancer cell DNA to stop tumor growth and is typically administered as part of combination chemotherapy regimens.

Key Facts

Brand Name
Oxaliplatin
Generic Name
Oxaliplatin
NDC Code (Product)
68083-170
Manufacturer
Gland Pharma Limited
Strength
50 mg/10mL
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA207385
Drug Class
Platinum-based Drug [EPC]
Marketing Start
05/29/2017

Recall History

4 Recalls on Record
Class II08/29/2019

Johnson Matthey Inc.

cGMP Deviations: Potential glass contamination

TerminatedVoluntary: Firm initiated
Class II02/06/2012

sanofi-aventis US, Inc.

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class II02/06/2012

sanofi-aventis US, Inc.

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class II06/12/2019

Infusion Options, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea6,740 reports
nausea5,282 reports
off label use4,512 reports
vomiting4,301 reports
disease progression4,233 reports
neuropathy peripheral4,158 reports
neutropenia4,129 reports
thrombocytopenia3,458 reports
dyspnoea2,998 reports
pyrexia2,818 reports

Frequently Asked Questions

What is Oxaliplatin used for?

Oxaliplatin is a platinum-based chemotherapy medication given by intravenous injection used to treat colorectal cancer and other cancers. It works by damaging cancer cell DNA to stop tumor growth and is typically administered as part of combination chemotherapy regimens.

Is Oxaliplatin a controlled substance?

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

What is the generic name for Oxaliplatin?

The generic name for Oxaliplatin is Oxaliplatin. There are 1 other brand versions of Oxaliplatin.

What is the NDC code for Oxaliplatin 50 mg/10mL?

The NDC (National Drug Code) for Oxaliplatin 50 mg/10mL is 68083-170, listed by Gland Pharma Limited.