PACLITAXEL
Generic: PACLITAXEL
HospiraManufacturer
INTRAVENOUSRoute
PACLITAXELActive Substance
2002-05-08Original Approval
PACLITAXEL is FDA application ANDA076131, sponsored by HOSPIRA. 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 II2012-06-27
Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for HospiraThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and
Class III2013-11-08
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; ManLabeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical S
Top Reported Reactions
1
NAUSEA
4,626 reports
2
DYSPNOEA
4,603 reports
3
NEUTROPENIA
4,498 reports
4
OFF LABEL USE
4,421 reports
5
DIARRHOEA
4,273 reports
6
ANAEMIA
3,943 reports
7
MALIGNANT NEOPLASM PROGRESSION
3,786 reports
8
DISEASE PROGRESSION
3,422 reports
9
MYELOSUPPRESSION
3,422 reports
10
FATIGUE
3,400 reports