HEPARIN SODIUM IN SODIUM CHLORIDE

Generic: HEPARIN SODIUM

Baxter Healthcare CorporationManufacturer
INTRAVENOUSRoute
HEPARIN SODIUMActive Substance
1982-04-28Original Approval

HEPARIN SODIUM IN SODIUM CHLORIDE is FDA application NDA018609, sponsored by BAXTER HLTHCARE. 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 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 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 I2024-08-01
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Class II2015-06-03
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only,

Subpotent Drug; out of specification results for heparin raw material

Class II2022-12-29
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case

Lack of assurance of sterility: Bags have the potential to leak.

Class II2014-06-06
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Si

Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of

Class I2014-09-11
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexib

Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the

Class II2023-02-28
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutan

Labeling: Not elsewhere classified

Class II2023-05-09
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B.

Subpotent: Low anti-factor IIa Potency.

Class II2014-10-30
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, M

Subpotent Drug: Heparin raw material was found to have low potency

Top Reported Reactions

1
HEPARIN-INDUCED THROMBOCYTOPENIA
1,308 reports
2
DRUG INEFFECTIVE
1,271 reports
3
OFF LABEL USE
768 reports
4
NAUSEA
755 reports
5
DRUG HYPERSENSITIVITY
637 reports
6
VOMITING
619 reports
7
HYPOTENSION
571 reports
8
DYSPNOEA
555 reports
9
PULMONARY EMBOLISM
518 reports
10
SEPSIS
503 reports