SODIUM ACETATE

Generic: SODIUM ACETATE, SODIUM ACETATE INJECTION, USP, 200 MEQ/100 ML, SODIUM ACETATE INJECTION, USP, 400 MEQ/100 ML

MILLA PHARMACEUTICALS INC.Manufacturer
INTRAVENOUSRoute
SODIUM ACETATEActive Substance
2021-05-04Original Approval

SODIUM ACETATE is FDA application ANDA214805, sponsored by MILLA PHARMS. 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 I2022-03-04
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of i

Class II2013-02-26
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Top Reported Reactions

1
OFF LABEL USE
28 reports
2
PYREXIA
19 reports
3
NAUSEA
18 reports
4
DIARRHOEA
17 reports
5
DYSPNOEA
16 reports
6
DEATH
15 reports
7
PNEUMONIA
15 reports
8
ANAEMIA
14 reports
9
VOMITING
14 reports
10
DRUG INTOLERANCE
13 reports