FDA (Drugs) recall action 98581
The FDA (Drugs) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
Fresenius Kabi is recalling 0.45% Sodium Chloride Injection, USP in 250 mL freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling three batches of 5% Dextrose Injection, USP, 5 g per 100 mL in freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 2.5 g per 50 mL supplied in 100 mL freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 100 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 250 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 500 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi is recalling one batch of 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation, citing lack of assurance of sterility. Two batches are affected.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 12.5 g per 250 mL in freeflex bags, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation distributed by BD, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 100 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi USA, LLC is recalling certain batches of 0.9% Sodium Chloride Injection due to concerns regarding sterility assurance.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by Fresenius Medical Care RTG, citing lack of assurance of sterility.