MAGNESIUM SULFATE IN WATER
Generic: MAGNESIUM SULFATE HEPTAHYDRATE
B. Braun Medical Inc.Manufacturer
INTRAVENOUSRoute
MAGNESIUM SULFATE HEPTAHYDRATEActive Substance
2021-04-26Original Approval
MAGNESIUM SULFATE IN WATER is FDA application ANDA207967, 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 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
Top Reported Reactions
1
RESPIRATORY FAILURE
35 reports
2
CONDITION AGGRAVATED
33 reports
3
MATERNAL EXPOSURE DURING PREGNANCY
11 reports
4
ABORTION INDUCED
8 reports
5
BURKHOLDERIA TEST POSITIVE
8 reports
6
CEREBRAL HAEMORRHAGE FOETAL
8 reports
7
DYSPNOEA
8 reports
8
HYPOTENSION
8 reports
9
SCHIZENCEPHALY
8 reports
10
EXPOSURE DURING PREGNANCY
7 reports