FEBUXOSTAT

Generic: FEBUXOSTAT

Aurobindo Pharma LimitedManufacturer

ORALRoute

FEBUXOSTATActive Substance

2023-10-25Original Approval

FEBUXOSTAT is FDA application ANDA210741, sponsored by AUROBINDO PHARMA LTD. 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 II2024-01-25

Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus,

CGMP Deviations

Class II2024-03-04

Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu

Class II2024-03-04

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu

Class II2024-01-18

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu

Class II2024-01-18

Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu

Top Reported Reactions

1

ACUTE KIDNEY INJURY

612 reports

2

OFF LABEL USE

556 reports

3

DIARRHOEA

538 reports

4

ANAEMIA

501 reports

5

NAUSEA

490 reports

6

RENAL IMPAIRMENT

446 reports

7

PYREXIA

434 reports

8

DYSPNOEA

402 reports

9

RASH

399 reports

10

DRUG INEFFECTIVE

389 reports