CARBOPLATIN
Generic: CARBOPLATIN
Gland Pharma LimitedManufacturer
INTRAVENOUSRoute
CARBOPLATINActive Substance
2017-02-15Original Approval
CARBOPLATIN is FDA application ANDA207324, sponsored by GLAND. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2012-07-02
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL mulFailed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API l
Class I2012-11-08
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NCrystallization: Product is being recalled due to visible particulates identified during a retain sa
Class II2012-06-27
Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for HospiThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and
Class I2012-11-08
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, HCrystallization: Product is being recalled due to visible particulates identified during a retain sa
Top Reported Reactions
1
OFF LABEL USE
8,564 reports
2
NEUTROPENIA
7,436 reports
3
ANAEMIA
7,235 reports
4
NAUSEA
7,052 reports
5
FEBRILE NEUTROPENIA
6,609 reports
6
DIARRHOEA
6,243 reports
7
MALIGNANT NEOPLASM PROGRESSION
6,115 reports
8
DISEASE PROGRESSION
6,076 reports
9
THROMBOCYTOPENIA
5,937 reports
10
DYSPNOEA
5,430 reports