SODIUM CHLORIDE

Generic: SODIUM CHLORIDE

LABORATORIOS GRIFOLS SAManufacturer

INTRAVENOUSRoute

SODIUM CHLORIDEActive Substance

2017-05-25Original Approval

SODIUM CHLORIDE is FDA application ANDA207956, sponsored by LABORATORIOS GRIFOLS. 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 II2017-07-06

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL

Lack of Assurance of Sterility: Customer complaints for leaking bags.

Class II2021-03-09

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-

Class I2015-12-15

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Co

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the p

Class I2018-11-15

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statemen

Class II2013-11-27

0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA

Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq

Class I2015-07-17

0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, De

Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single

Class II2025-08-04

0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose containe

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class II2026-08-06

Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only

CGMP Deviations

Class II2026-03-11

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Frese

Lack of Assurance of Sterility

Class II2026-03-11

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only,

SODIUM CHLORIDE

Recalls

Top Reported Reactions