IRINOTECAN HYDROCHLORIDE
Generic: IRINOTECAN HYDROCHLORIDE
Apotex Corp.Manufacturer
INTRAVENOUSRoute
IRINOTECAN HYDROCHLORIDEActive Substance
2016-05-03Original Approval
IRINOTECAN HYDROCHLORIDE is FDA application ANDA203380, sponsored by QILU PHARM HAINAN. 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 II2013-09-23
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to dete
Class II2013-09-23
Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured bSuperpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to dete
Class II2020-06-11
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2Defective Container: Customer complaints received of a crimp defect while removing the flip-cap duri
Class II2020-06-11
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2Defective Container: Customer complaints received of a crimp defect while removing the flip-cap duri
Top Reported Reactions
1
DIARRHOEA
858 reports
2
OFF LABEL USE
704 reports
3
MYELOSUPPRESSION
664 reports
4
NAUSEA
478 reports
5
FEBRILE NEUTROPENIA
475 reports
6
VOMITING
403 reports
7
NEUTROPENIA
376 reports
8
NEUROPATHY PERIPHERAL
364 reports
9
NEOPLASM PROGRESSION
322 reports
10
DISEASE PROGRESSION
317 reports