NELARABINE
Generic: NELARABINE
Amneal Pharmaceuticals LLCManufacturer
INTRAVENOUSRoute
NELARABINEActive Substance
2023-04-04Original Approval
NELARABINE is FDA application ANDA216346, sponsored by AMNEAL. 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 II2025-02-13
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL SingFailed Impurities/Degradation Specifications
Class II2025-02-13
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL SingFailed Impurities/Degradation Specifications
Top Reported Reactions
1
DRUG INEFFECTIVE
64 reports
2
FEBRILE NEUTROPENIA
54 reports
3
NEUROTOXICITY
52 reports
4
OFF LABEL USE
51 reports
5
PERIPHERAL SENSORY NEUROPATHY
49 reports
6
MYELOPATHY
47 reports
7
SEPSIS
45 reports
8
MUSCULAR WEAKNESS
40 reports
9
NEUROPATHY PERIPHERAL
40 reports
10
NEUTROPENIA
38 reports