DEXTROSE

Generic: DEXTROSE MONOHYDRATE

Becton Dickinson and CompanyManufacturer
INTRAVENOUSRoute
DEXTROSE MONOHYDRATEActive Substance
2018-07-16Original Approval

DEXTROSE is FDA application ANDA209448, sponsored by FRESENIUS KABI USA. 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 II2017-05-15
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Hea

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Class II2019-10-02
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Fores

Lack of Assurance of Sterility: Bag has the potential to leak.

Class I2013-11-21
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Si

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due t

Class II2023-03-01
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B

Subpotent Drug: low Anti-Factor IIa potency.

Class II2017-07-06
5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 6001

Lack of Assurance of Sterility: Bags have the potential to leak.

Class I2014-08-07
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Class II2023-08-11
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx O

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Class II2015-03-18
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may c

Class II2019-06-13
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag,

Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potenc

Class I2013-10-15
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, Fo

Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot ha

Top Reported Reactions

1
DRUG INEFFECTIVE
13,061 reports
2
OFF LABEL USE
10,977 reports
3
NAUSEA
10,131 reports
4
DYSPNOEA
9,969 reports
5
DIARRHOEA
8,895 reports
6
FATIGUE
8,870 reports
7
PAIN
8,864 reports
8
PYREXIA
8,028 reports
9
ACUTE KIDNEY INJURY
7,940 reports
10
VOMITING
7,679 reports