MESALAMINE
Generic: MESALAMINE
Padagis Israel Pharmaceuticals LtdManufacturer
RECTALRoute
MESALAMINEActive Substance
2004-09-17Original Approval
MESALAMINE is FDA application ANDA076751, sponsored by PADAGIS ISRAEL. 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 II2024-02-05
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical IFailed Dissolution Specifications: Out of specification for dissolution.
Class II2024-01-18
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: SCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
Class II2020-10-28
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis LaboratoriesFailed Dissolution Specifications: Out-of-specification dissolution results were obtained during sta
Class II2020-02-20
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Failed Dissolution Specifications: Low out of specification dissolution result observed during stabi
Top Reported Reactions
1
OFF LABEL USE
6,345 reports
2
COLITIS ULCERATIVE
4,485 reports
3
DRUG INEFFECTIVE
4,292 reports
4
CONDITION AGGRAVATED
3,290 reports
5
DIARRHOEA
2,574 reports
6
HAEMATOCHEZIA
2,421 reports
7
FATIGUE
2,167 reports
8
ABDOMINAL PAIN
2,129 reports
9
WEIGHT DECREASED
1,873 reports
10
HEADACHE
1,839 reports