MAGNESIUM SULFATE IN DEXTROSE

Generic: MAGNESIUM SULFATE HEPTAHYDRATE

B. Braun Medical Inc.Manufacturer
INTRAVENOUSRoute
MAGNESIUM SULFATE HEPTAHYDRATEActive Substance
2020-10-27Original Approval

MAGNESIUM SULFATE IN DEXTROSE is FDA application ANDA207966, sponsored by B BRAUN MEDICAL. 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 I2015-03-06
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, N

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect bar

Top Reported Reactions

1
DRUG INEFFECTIVE
1,216 reports
2
OFF LABEL USE
846 reports
3
NAUSEA
839 reports
4
PYREXIA
794 reports
5
MATERNAL EXPOSURE DURING PREGNANCY
767 reports
6
PAIN
706 reports
7
FOETAL EXPOSURE DURING PREGNANCY
689 reports
8
PREMATURE BABY
672 reports
9
DIARRHOEA
642 reports
10
DYSPNOEA
598 reports