MYCOPHENOLATE MOFETIL
Generic: MYCOPHENOLATE MOFETIL
Wuxi Fortune Pharmaceutical Co.Manufacturer
ORALRoute
MYCOPHENOLATE MOFETILActive Substance
2024-11-07Original Approval
MYCOPHENOLATE MOFETIL is FDA application ANDA214079, sponsored by WUXI. 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 I2019-04-30
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical ChestPresence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class II2026-07-02
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: MPresence of precipitate
Class II2026-08-26
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, ManufacturedFailed Dissolution Specifications
Top Reported Reactions
1
OFF LABEL USE
15,818 reports
2
DRUG INEFFECTIVE
10,135 reports
3
PRODUCT USE IN UNAPPROVED INDICATION
6,913 reports
4
DIARRHOEA
5,041 reports
5
PYREXIA
4,487 reports
6
CYTOMEGALOVIRUS INFECTION
4,406 reports
7
PNEUMONIA
4,248 reports
8
CONDITION AGGRAVATED
3,831 reports
9
TRANSPLANT REJECTION
3,519 reports
10
INFECTION
3,370 reports