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 III2012-04-05
Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, HoSuperpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium
Class I2026-03-18
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bagsProduct mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually
Class I2016-01-05
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, HospLabeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which sca
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, NLabeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect bar
Top Reported Reactions
1
DRUG INEFFECTIVE
1,227 reports
2
NAUSEA
877 reports
3
OFF LABEL USE
849 reports
4
PYREXIA
796 reports
5
MATERNAL EXPOSURE DURING PREGNANCY
767 reports
6
PAIN
710 reports
7
FOETAL EXPOSURE DURING PREGNANCY
689 reports
8
PREMATURE BABY
672 reports
9
DIARRHOEA
651 reports
10
DYSPNOEA
602 reports