Drugplain

CISplatin 1 mg/mL

CISplatin · INJECTION, SOLUTION · WG Critical Care, LLC

6 Recalls on Record
Plain English

Cisplatin is a platinum-based chemotherapy medication given by injection into a vein to treat various types of cancer, including testicular, ovarian, bladder, and lung cancers. It works by damaging cancer cell DNA to stop tumor growth.

Key Facts

Brand Name
CISplatin
Generic Name
CISplatin
NDC Code (Product)
44567-511
Manufacturer
WG Critical Care, LLC
Strength
1 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA018057
Drug Class
Platinum-based Drug [EPC]
Marketing Start
04/15/2015

Recall History

6 Recalls on Record
Class II06/12/2019

Infusion Options, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II10/01/2024

ACCORD HEALTHCARE, INC.

Failed Impurities/Degradation Specifications.

TerminatedVoluntary: Firm initiated
Class II05/25/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class II06/12/2019

Infusion Options, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II08/29/2019

Johnson Matthey Inc.

cGMP Deviations: Potential glass contamination

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use5,721 reports
nausea5,375 reports
neutropenia4,790 reports
disease progression4,590 reports
vomiting4,522 reports
febrile neutropenia4,498 reports
anaemia3,966 reports
diarrhoea3,722 reports
thrombocytopenia3,710 reports
pyrexia3,354 reports

Frequently Asked Questions

What is CISplatin used for?

Cisplatin is a platinum-based chemotherapy medication given by injection into a vein to treat various types of cancer, including testicular, ovarian, bladder, and lung cancers. It works by damaging cancer cell DNA to stop tumor growth.

Is CISplatin a controlled substance?

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

What is the generic name for CISplatin?

The generic name for CISplatin is CISplatin. There are 8 other brand versions of CISplatin.

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

The NDC (National Drug Code) for CISplatin 1 mg/mL is 44567-511, listed by WG Critical Care, LLC.

Product NDC

44567-511

Package NDC

44567-511-01

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

Data from openFDA · Public domain (CC0 1.0)