SUCRALFATE
Generic: SUCRALFATE ORAL
TruPharmaManufacturer
ORALRoute
SUCRALFATEActive Substance
2024-01-17Original Approval
SUCRALFATE is FDA application ANDA213549, sponsored by PD PARTNERS. 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 II2023-08-30
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and DistribuSuperpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class I2023-10-18
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and DistMicrobial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Top Reported Reactions
1
NAUSEA
1,439 reports
2
DIARRHOEA
1,040 reports
3
FATIGUE
1,033 reports
4
PAIN
930 reports
5
HEADACHE
912 reports
6
OFF LABEL USE
870 reports
7
DRUG INEFFECTIVE
824 reports
8
VOMITING
820 reports
9
DYSPNOEA
802 reports
10
CHRONIC KIDNEY DISEASE
667 reports